Systems, devices, and methods for analyte monitoring

ABSTRACT

Applicator including a housing; a sensor carrier coupled to the housing, and including a first lock interface; a sheath, slidably coupled to the housing, the sheath including a first lock arm having an attached distal end and a free proximal end, the free proximal end including a first lock arm interface disposed on an inner surface of the first lock arm and a first sharp edge disposed on an outer surface of the first lock arm; and a cap threadably coupled to the housing, the cap including an inner surface having a first plurality of crush ribs. The inner surface of the cap is configured to urge the first lock arm inwardly such that the first lock arm interface engages the first lock interface; and the first sharp edge is configured to engage the first plurality of crush ribs during a shock event.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.63/078,703, filed Sep. 15, 2020, which is herein expressly incorporatedby reference in its entirety for all purposes.

FIELD

The subject matter described herein relates generally to systems,devices, and methods for in vivo analyte monitoring.

BACKGROUND

The detection and/or monitoring of analyte levels, such as glucose,ketones, lactate, oxygen, hemoglobin AIC, or the like, can be vitallyimportant to the health of an individual having diabetes. Patientssuffering from diabetes mellitus can experience complications includingloss of consciousness, cardiovascular disease, retinopathy, neuropathy,and nephropathy. Diabetics are generally required to monitor theirglucose levels to ensure that they are being maintained within aclinically safe range, and may also use this information to determine ifand/or when insulin is needed to reduce glucose levels in their bodies,or when additional glucose is needed to raise the level of glucose intheir bodies.

Growing clinical data demonstrates a strong correlation between thefrequency of glucose monitoring and glycemic control. Despite suchcorrelation, however, many individuals diagnosed with a diabeticcondition do not monitor their glucose levels as frequently as theyshould due to a combination of factors including convenience, testingdiscretion, pain associated with glucose testing, and cost.

To increase patient adherence to a plan of frequent glucose monitoring,in vivo analyte monitoring systems can be utilized, in which a sensorcontrol device may be worn on the body of an individual who requiresanalyte monitoring. To increase comfort and convenience for theindividual, the sensor control device may have a small form-factor, andcan be assembled and applied by the individual with a sensor applicator.The application process includes inserting a sensor that senses a user'sanalyte level in a bodily fluid located in the human body, using anapplicator or insertion mechanism, such that the sensor comes intocontact with a bodily fluid. The sensor control device may also beconfigured to transmit analyte data to another device, from which theindividual or her health care provider (“HCP”) can review the data andmake therapy decisions.

While current sensors can be convenient for users, they are alsosusceptible to malfunctions due to improper insertion. Thesemalfunctions can be caused by user error, lack of proper training, pooruser coordination, overly complicated procedures, and other issues. Thiscan be particularly true for analyte monitoring systems having sensorsused to measure an analyte level in an interstitial fluid (“ISF”), andwhich are inserted using sharps (also known as “introducers” or“needles”). Some prior art systems, for example, may rely too much onthe precision assembly and deployment of a sensor control device and anapplicator by the individual user. Other prior art systems may utilizesharp insertion and retraction mechanisms that are susceptible topremature withdrawal before the sensor can be properly implanted. Inaddition, some prior art systems may utilize sharps that are notoptimally configured to create an insertion path without creating traumato surrounding tissue. These challenges and others described herein canlead to improperly inserted or damaged sensors, and consequently, afailure to properly monitor the patient's analyte level.

Thus, a need exists for more reliable sensor insertion devices, systemsand methods, that are easy to use by the patient and less prone toerror.

SUMMARY

The purpose and advantages of the disclosed subject matter will be setforth in and apparent from the description that follows, as well as willbe learned by practice of the disclosed subject matter. Additionaladvantages of the disclosed subject matter will be realized and attainedby the methods and systems particularly pointed out in the writtendescription and claims hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosed subject matter, as embodied and broadly described, thedisclosed subject matter is directed to an applicator for delivering asensor control device. The applicator can include a housing; a sensorcarrier coupled to the housing, the sensor carrier including a firstlock interface; a sheath, slidably coupled to the housing to movebetween an extended position and a collapsed position, the sheathincluding a first lock arm having an attached distal end and a freeproximal end, the free proximal end including a first lock arm interfacedisposed on an inner surface of the first lock arm and a first edge,such as a first sharp edge, disposed on an outer surface of the firstlock arm; and a cap threadably coupled to the housing, the cap includingan inner surface having a first plurality of ribs, wherein the ribs canbe crush ribs. The inner surface of the cap is configured to urge thefirst lock arm inwardly when the cap is coupled to the housing such thatthe first lock arm interface engages the first lock interface; and thefirst sharp edge is configured to engage the first plurality of crushribs during a shock event.

The sensor carrier can include a second lock interface; and the sheathcan include a second lock arm having an attached distal end and a freeproximal end. The free proximal end can include a second lock arminterface disposed on an inner surface of the second lock arm and asecond edge, such as a second sharp edge, disposed on an outer surfaceof the first lock arm. The inner surface of the cap can be configured tourge the second lock arm inwardly when the cap is coupled to the housingsuch that the second lock arm interface engages the second lockinterface. The cap can include a second plurality of crush ribs; and thesecond sharp edge can be configured to engage the second plurality ofcrush ribs during the shock event. The first lock arm interface can be aU-shape. The first lock interface can be disposed on a perimeter of thesensor carrier.

The applicator can include housing skirt coupled to the housing by aplurality of skirt stiffening ribs. A tamper evidence feature can becoupled to each of the housing skirt and the cap. The tamper evidencefeature can be a sticker. The housing can be cyclic olefin copolymer.The sheath can be Delrin. The cap can be high density polyethylene.

In accordance with the disclosed subject matter, the sensor carrier caninclude a base having a first half and a second half. A first sensorretention arm can be coupled to the first half of the base at a firstend portion of the first sensor retention arm and include a free secondend portion extending toward the second half of the base. The firstsensor retention arm can include a first sensor retention feature on aninner surface of the first sensor retention arm and the first lockinterface can be disposed on an outer surface of the first sensorretention arm.

The sensor carrier can include three equally spaced housing attachmentfeatures extending upwardly from a top surface of the base. Each housingattachment feature can include: a housing snap; a housing locatingfeature; and a housing biasing feature. The housing can include threesensor carrier attachment features, each configured to engage one of thesensor carrier housing attachment features.

The cap can include a sheath support surface configured to engage thesheath and limit movement of the sheath during the shock event.Additionally or alternatively, the cap can include a raised ridgeconfigured to limit movement of the sensor carrier during a shock event

In accordance with the disclosed subject matter, a sensor carrier foruse in an applicator for delivering a sensor control device is provided.The sensor carrier includes a base having a first half and a secondhalf; a first sensor retention arm coupled to the first half of the baseat a first end portion of the first sensor retention arm and having afree second end portion extending toward the second half of the base,the first sensor retention arm including a first sensor retentionfeature on an inner surface of the first sensor retention arm and afirst lock interface on an outer surface of the first sensor retentionarm; and a second sensor retention arm coupled to the first half of thebase at a first end portion of the second sensor retention arm andhaving a free second end portion extending toward the second half of thebase, the second sensor retention arm including a second sensorretention feature on an inner surface of the second sensor retention armand a second lock interface on an outer surface of the second sensorretention arm.

The sensor carrier can include three equally spaced housing attachmentfeatures extending upwardly from a top surface of the base. Each housingattachment feature can include: a housing snap; a housing locatingfeature; and a housing biasing feature. A first housing attachmentfeature of the three housing attachment features can be disposed on thesecond half of the base; and a second housing attachment feature and athird housing attachment feature of the three housing attachmentfeatures can be disposed on the first half of the base.

The sensor carrier can include three equally spaced sharp carrier lockarms extending upwardly from the top surface of the base. Each sharpcarrier lock arm can include a sharp carrier retention feature and asharp carrier retention feature rib. A first sharp carrier lock arm ofthe three sharp carrier lock arms can be disposed on the first half ofthe base. A second sharp carrier lock arm and a third sharp carrier lockarm of the three sharp carrier lock arms can be disposed on the secondhalf of the base.

The sensor carrier can include a first lock ledge and a second lockledge. The sensor carrier can include a hole extending through a middleof the base.

In accordance with another aspect of the disclosed subject matter, anapplicator for delivering a sensor control device is provided. Theapplicator includes: a housing; a sensor carrier coupled to the housing;a sheath, slidably coupled to the housing to move between an extendedposition and a collapsed position; and a sharp carrier, moveable betweena distal position relative the sheath and a proximal position relativethe sheath. The sheath further includes a noise damper configured toengage the sharp carrier and reduce a speed of the sharp carrier as thesharp carrier moves from the distal position to the proximal position.

The noise damper can be configured to reduce a noise caused by the sharpcarrier moving from the distal to the proximal position. The applicatorcan include a cap threadably coupled to the housing.

In accordance with the disclose subject matter, an applicator fordelivering a sensor control device is provided. The applicator includes:a housing; a sensor carrier coupled to the housing; a sensor controldevice releasably coupled to the sensor carrier; a sensor extending fromthe sensor control device and having a tail including a distal endportion and a proximal end portion; and a sharp carrier, moveablebetween a distal position relative to the sensor control device and aproximal position relative to the sensor control device; and a sharpdisposed within the sharp carrier. The sharp engages the proximal endportion of the tail to bias the distal end portion of the tail towardthe sharp when the sharp carrier is in the distal position, and thesharp does not engage the proximal end portion of the tail when thesharp carrier is in the proximal position.

The proximal end portion of the sensor can include a protrusion. Thesharp can include a window, and the proximal end portion of the tail canextend within the window of the sharp when the sharp is in the distalposition. The sharp carrier can be in the distal position prior todelivery. The sharp carrier can be in the proximal position duringdelivery of the sensor. The applicator can include a sheath, slidablycoupled to the housing to move between an extended position and acollapsed position. The sharp can define a channel. The distal endportion of the tail can be received within the channel of the sharp whenthe sharp engages the proximal end portion of the tail.

BRIEF DESCRIPTION OF THE FIGURES

The details of the subject matter set forth herein, both as to itsstructure and operation, may be apparent by study of the accompanyingfigures, in which like reference numerals refer to like parts. Thecomponents in the figures are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles of the subject matter.Moreover, all illustrations are intended to convey concepts, whererelative sizes, shapes and other detailed attributes may be illustratedschematically rather than literally or precisely.

FIG. 1 is a system overview of a sensor applicator, reader device,monitoring system, network, and remote system.

FIG. 2A is a block diagram depicting an example embodiment of a readerdevice.

FIGS. 2B and 2C are block diagrams depicting example embodiments ofsensor control devices.

FIG. 3A is a proximal perspective view depicting an example embodimentof a user preparing a tray for an assembly.

FIG. 3B is a side view depicting an example embodiment of a userpreparing an applicator device for an assembly.

FIG. 3C is a proximal perspective view depicting an example embodimentof a user inserting an applicator device into a tray during an assembly.

FIG. 3D is a proximal perspective view depicting an example embodimentof a user removing an applicator device from a tray during an assembly.

FIG. 3E is a proximal perspective view depicting an example embodimentof a patient applying a sensor using an applicator device.

FIG. 3F is a proximal perspective view depicting an example embodimentof a patient with an applied sensor and a used applicator device.

FIG. 4A is a side view depicting an example embodiment of an applicatordevice coupled with a cap.

FIG. 4B is a side perspective view depicting an example embodiment of anapplicator device and cap decoupled.

FIG. 4C is a perspective view depicting an example embodiment of adistal end of an applicator device and electronics housing.

FIG. 4D is a top perspective view of an exemplary applicator device inaccordance with the disclosed subject matter.

FIG. 4E is a bottom perspective view of the applicator device of FIG.4D.

FIG. 4F is an exploded view of the applicator device of FIG. 4D.

FIG. 4G is a side cutaway view of the applicator device of FIG. 4D.

FIG. 5 is a proximal perspective view depicting an example embodiment ofa tray with sterilization lid coupled.

FIG. 6A is a proximal perspective cutaway view depicting an exampleembodiment of a tray with sensor delivery components.

FIG. 6B is a proximal perspective view depicting sensor deliverycomponents.

FIG. 7A is side view depicting an example embodiment of a housing.

FIG. 7B is a perspective view depicting an example embodiment of adistal end of a housing.

FIG. 7C is a side cross-sectional view depicting an example embodimentof a housing.

FIGS. 7D and 7E are side cross-sectional views depicting a locking ribportion of an example embodiment of a housing with a portion of asheath.

FIGS. 7F and 7G are side cross-sectional views depicting a locking ribportion of another example embodiment of a housing and a portion of asheath.

FIG. 7H is a side cross-sectional view depicting a locking rib portionof another example embodiment of a housing and a portion of a sheath.

FIG. 7I is a side cross-sectional view depicting a locking rib portionof another example embodiment of a housing and a portion of a sheath.

FIG. 7J is a side view of an exemplary housing in accordance with thedisclosed subject matter.

FIG. 7K is a bottom perspective view of the housing of FIG. 7J.

FIG. 7L is a side cutaway view of the housing of FIG. 7J.

FIG. 7M is bottom perspective view of a cap in accordance with thedisclosed subject matter.

FIG. 7N is a side cutaway view of the cap of FIG. 7M.

FIG. 7O is a top view of the cap of FIG. 7M.

FIGS. 7P-Q are enlarged cross-sectional side views of the interfacebetween the housing and cap in accordance with the disclosed subjectmatter.

FIGS. 7R-S are enlarged cross-sectional side views of the housing andcap, respectively, in accordance with the disclosed subject matter.

FIGS. 7T-U are side cutaway views of the cap of FIG. 7M.

FIG. 8A is a side view depicting an example embodiment of a sheath.

FIG. 8B is a perspective view depicting an example embodiment of aproximal end of a sheath.

FIG. 8C is a close-up perspective view depicting an example embodimentof a distal side of a detent snap of a sheath.

FIG. 8D is a side view depicting an example embodiment of features of asheath.

FIG. 8E is an end view of an example embodiment of a proximal end of asheath.

FIGS. 8F to 8H are perspective views depicting another exampleembodiment of a sheath in various stages of assembly with otherapplicator components.

FIG. 8I is a side view of a sheath in accordance with the disclosedsubject matter.

FIG. 8J is a close-up view of a detent snap of the sheath of FIG. 8I.

FIG. 8K is a top view of the sheath of FIG. 8I.

FIG. 8L is a perspective view of the sheath of FIG. 8I.

FIG. 8M is a side cutaway view of the sheath of FIG. 8I.

FIG. 8N is a close-up view a lock arm of the sheath of FIG. 8I and thelock arm's engagement with a cap and a sensor carrier, in accordancewith the disclosed subject matter.

FIG. 8O is a close-up view of a rib of the sheath of FIG. 8I and therib's engagement with a sensor carrier, in accordance with the disclosedsubject matter.

FIG. 9A is a proximal perspective view depicting an example embodimentof a sensor carrier.

FIG. 9B is a distal perspective view depicting an example embodiment ofa sensor carrier.

FIG. 9C is a distal perspective view depicting another exampleembodiment of a sensor carrier.

FIG. 9D is a top perspective view of a sensor carrier in accordance withthe disclosed subject matter.

FIG. 9E is a bottom view of the sensor carrier of FIG. 9D.

FIG. 10A is a perspective view of a sharp carrier in accordance with thedisclosed subject matter.

FIG. 10B is a side cutaway view of the sharp carrier of FIG. 10A.

FIG. 10C is a perspective view of a sharp carrier in accordance with thedisclosed subject matter.

FIG. 10D is a side cutaway view of the sharp carrier of FIG. 10C.

FIGS. 11A to 11B are top and bottom perspective views, respectively,depicting an example embodiment of a sensor module.

FIGS. 12A and 12B are perspective and compressed views, respectively,depicting an example embodiment of a sensor connector.

FIG. 13 is a perspective view depicting an example embodiment of asensor.

FIGS. 14A and 14B are bottom and top perspective views, respectively, ofan example embodiment of a sensor module assembly.

FIGS. 15A and 15B are close-up partial views of an example embodiment ofa sensor module assembly.

FIGS. 15C-G are side views of exemplary sensors, according to one ormore embodiments of the disclosure.

FIGS. 16A and 16B are isometric and partially exploded isometric viewsof an example connector assembly, according to one or more embodiments.

FIG. 16C is an isometric bottom view of the connector of FIGS. 16A-16B.

FIGS. 16D and 16E are isometric and partially exploded isometric viewsof another example connector assembly, according to one or moreembodiments.

FIG. 16F is an isometric bottom view of the connector of FIGS. 16D-16E.

FIG. 17A is a perspective view depicting an example embodiment of asharp module.

FIG. 17B is a perspective view of another example embodiment of a sharpmodule.

FIGS. 17C and 17D are schematic views depicting the sharp module of FIG.17B.

FIGS. 17E and 17F are a side schematic view and a top-down schematicview, respectively, of the sharp module of FIG. 17B, as assembled with asensor module.

FIG. 17G is a perspective view of another example embodiment of a sharpmodule.

FIG. 17H is a side schematic view depicting the sharp module of FIG.17G. FIGS. 17I and 17J are a side cross-sectional view and a side view,respectively, of the sharp module of FIG. 17G, as assembled with asensor module.

FIGS. 18A and 18B are isometric and side views, respectively, of anotherexample sensor control device.

FIGS. 19A and 19B are exploded isometric top and bottom views,respectively of the sensor control device of FIGS. 18A-18B.

FIG. 20 is a cross-sectional side view of an assembled sealedsubassembly, according to one or more embodiments.

FIGS. 21A-21C are progressive cross-sectional side views showingassembly of the sensor applicator with the sensor control device ofFIGS. 18A-18B.

FIGS. 22A and 22B are perspective and top views, respectively, of thecap post of FIG. 21C, according to one or more additional embodiments.

FIG. 23 is a cross-sectional side view of the sensor control device ofFIGS. 18A-18B.

FIGS. 24A and 24B are cross-sectional side views of the sensorapplicator ready to deploy the sensor control device to a targetmonitoring location.

FIGS. 25A-25C are progressive cross-sectional side views showingassembly and disassembly of an example embodiment of the sensorapplicator with the sensor control device of FIGS. 18A-18B.

FIG. 26A is an isometric bottom view of the housing, according to one ormore embodiments.

FIG. 27A is an isometric bottom view of the housing with the sheath andother components at least partially positioned therein.

FIG. 28 is an enlarged cross-sectional side view of the sensorapplicator with the sensor control device installed therein, accordingto one or more embodiments.

FIG. 29A is an isometric top view of the cap, according to one or moreembodiments.

FIG. 29B is an enlarged cross-sectional view of the engagement betweenthe cap and the housing, according to one or more embodiments.

FIGS. 30A and 30B are isometric views of the sensor cap and the collar,respectively, according to one or more embodiments.

FIGS. 31A and 31B are side and isometric views, respectively, of anexample sensor control device, according to one or more embodiments ofthe present disclosure.

FIGS. 32A and 32B are exploded, isometric top and bottom views,respectively, of the sensor control device of FIG. 2, according to oneor more embodiments.

FIG. 33 is a cross-sectional side view of the sensor control device ofFIGS. 31A-31B and 32A-32B, according to one or more embodiments.

FIG. 33A is an exploded isometric view of a portion of anotherembodiment of the sensor control device of FIGS. 31A-31B and 32A-32B.

FIG. 34A is an isometric bottom view of the mount of FIGS. 31A-31B and32A-32B.

FIG. 34B is an isometric top view of the sensor cap of FIGS. 31A-31B and32A-32B.

FIGS. 35A and 35B are side and cross-sectional side views, respectively,of an example sensor applicator, according to one or more embodiments.

FIGS. 36A and 36B are perspective and top views, respectively, of thecap post of FIG. 35B, according to one or more embodiments.

FIG. 37 is a cross-sectional side view of the sensor control devicepositioned within the applicator cap, according to one or moreembodiments.

FIG. 38A is a cross-sectional view of a sensor control device showingexample interaction between the sensor and the sharp.

FIG. 38B is a side cross-sectional view of a sharp hub, sharp, andsensor, with the sensor in an unbiased position, in accordance with thedisclosed subject matter.

FIG. 38C is a side cross-sectional view of a sharp hub, sharp, andsensor, with the sensor in a biased position, in accordance with thedisclosed subject matter.

FIG. 38D is a closeup of a portion of a sharp in accordance with thedisclosed subject matter.

FIGS. 39A-39F illustrate cross-sectional views depicting an exampleembodiment of an applicator during a stage of deployment.

DETAILED DESCRIPTION

Before the present subject matter is described in detail, it is to beunderstood that this disclosure is not limited to the particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

Generally, embodiments of the present disclosure include systems,devices, and methods for the use of analyte sensor insertion applicatorsfor use with in vivo analyte monitoring systems. An applicator can beprovided to the user in a sterile package with an electronics housing ofthe sensor control device contained therein. According to someembodiments, a structure separate from the applicator, such as acontainer, can also be provided to the user as a sterile package with asensor module and a sharp module contained therein. The user can couplethe sensor module to the electronics housing, and can couple the sharpto the applicator with an assembly process that involves the insertionof the applicator into the container in a specified manner. In otherembodiments, the applicator, sensor control device, sensor module, andsharp module can be provided in a single package. The applicator can beused to position the sensor control device on a human body with a sensorin contact with the wearer's bodily fluid. The embodiments providedherein are improvements to reduce the likelihood that a sensor isimproperly inserted or damaged, or elicits an adverse physiologicalresponse. Other improvements and advantages are provided as well. Thevarious configurations of these devices are described in detail by wayof the embodiments which are only examples.

Furthermore, many embodiments include in vivo analyte sensorsstructurally configured so that at least a portion of the sensor is, orcan be, positioned in the body of a user to obtain information about atleast one analyte of the body. It should be noted, however, that theembodiments disclosed herein can be used with in vivo analyte monitoringsystems that incorporate in vitro capability, as well as purely in vitroor ex vivo analyte monitoring systems, including systems that areentirely non-invasive.

Furthermore, for each and every embodiment of a method disclosed herein,systems and devices capable of performing each of those embodiments arecovered within the scope of the present disclosure. For example,embodiments of sensor control devices are disclosed, and these devicescan have one or more sensors, analyte monitoring circuits (e.g., ananalog circuit), memories (e.g., for storing instructions), powersources, communication circuits, transmitters, receivers, processorsand/or controllers (e.g., for executing instructions) that can performany and all method steps or facilitate the execution of any and allmethod steps. These sensor control device embodiments can be used andcan be capable of use to implement those steps performed by a sensorcontrol device from any and all of the methods described herein.

As mentioned, a number of embodiments of systems, devices, and methodsare described herein that provide for the improved assembly and use ofsensor insertion devices for use with in vivo analyte monitoringsystems. In particular, several embodiments of the present disclosureare designed to improve the method of sensor insertion with respect toin vivo analyte monitoring systems and, in particular, to prevent thepremature retraction of an insertion sharp during a sensor insertionprocess. Some embodiments, for example, include a sensor insertionmechanism with an increased firing velocity and a delayed sharpretraction. In other embodiments, the sharp retraction mechanism can bemotion-actuated such that the sharp is not retracted until the userpulls the applicator away from the skin. Consequently, these embodimentscan reduce the likelihood of prematurely withdrawing an insertion sharpduring a sensor insertion process; decrease the likelihood of impropersensor insertion; and decrease the likelihood of damaging a sensorduring the sensor insertion process, to name a few advantages. Severalembodiments of the present disclosure also provide for improvedinsertion sharp modules. In addition, several embodiments of the presentdisclosure are designed to prevent undesirable axial and/or rotationalmovement of applicator components during sensor insertion. Accordingly,these embodiments can reduce the likelihood of instability of apositioned sensor, irritation at the insertion site, and damage tosurrounding tissue, to name a few advantages. In addition, to mitigateinaccurate sensor readings which can be caused by trauma at theinsertion site, several embodiments of the present disclosure can reducethe end-depth penetration of the needle relative to the sensor tipduring insertion.

Before describing these aspects of the embodiments in detail, however,it is first desirable to describe examples of devices that can bepresent within, for example, an in vivo analyte monitoring system, aswell as examples of their operation, all of which can be used with theembodiments described herein.

There are various types of in vivo analyte monitoring systems.“Continuous Analyte Monitoring” systems (or “Continuous GlucoseMonitoring” systems), for example, can transmit data from a sensorcontrol device to a reader device continuously without prompting, e.g.,automatically according to a schedule. “Flash Analyte Monitoring”systems (or “Flash Glucose Monitoring” systems or simply “Flash”systems), as another example, can transfer data from a sensor controldevice in response to a scan or request for data by a reader device,such as with a Near Field Communication (NFC) or Radio FrequencyIdentification (RFID) protocol. In vivo analyte monitoring systems canalso operate without the need for finger stick calibration.

In vivo analyte monitoring systems can be differentiated from “in vitro”systems that contact a biological sample outside of the body (or “exvivo”) and that typically include a meter device that has a port forreceiving an analyte test strip carrying bodily fluid of the user, whichcan be analyzed to determine the user's blood sugar level.

In vivo monitoring systems can include a sensor that, while positionedin vivo, makes contact with the bodily fluid of the user and senses theanalyte levels contained therein. The sensor can be part of the sensorcontrol device that resides on the body of the user and contains theelectronics and power supply that enable and control the analytesensing. The sensor control device, and variations thereof, can also bereferred to as a “sensor control unit,” an “on-body electronics” deviceor unit, an “on-body” device or unit, or a “sensor data communication”device or unit, to name a few.

In vivo monitoring systems can also include a device that receivessensed analyte data from the sensor control device and processes and/ordisplays that sensed analyte data, in any number of forms, to the user.This device, and variations thereof, can be referred to as a “handheldreader device,” “reader device” (or simply a “reader”), “handheldelectronics” (or simply a “handheld”), a “portable data processing”device or unit, a “data receiver,” a “receiver” device or unit (orsimply a “receiver”), or a “remote” device or unit, to name a few. Otherdevices such as personal computers have also been utilized with orincorporated into in vivo and in vitro monitoring systems.

Exemplary In Vivo Analyte Monitoring System

FIG. 1 is a conceptual diagram depicting an example embodiment of ananalyte monitoring system 100 that includes a sensor applicator 150, asensor control device 102, and a reader device 120. Here, sensorapplicator 150 can be used to deliver sensor control device 102 to amonitoring location on a user's skin where a sensor 104 is maintained inposition for a period of time by an adhesive patch 105. Sensor controldevice 102 is further described in FIGS. 2B and 2C, and can communicatewith reader device 120 via a communication path 140 using a wired orwireless technique. Example wireless protocols include Bluetooth,Bluetooth Low Energy (BLE, BTLE, Bluetooth SMART, etc.), Near FieldCommunication (NFC) and others. Users can monitor applications installedin memory on reader device 120 using screen 122 and input 121 and thedevice battery can be recharged using power port 123. More detail aboutreader device 120 is set forth with respect to FIG. 2A below. Readerdevice 120 can communicate with local computer system 170 via acommunication path 141 using a wired or wireless technique. Localcomputer system 170 can include one or more of a laptop, desktop,tablet, phablet, smartphone, set-top box, video game console, or othercomputing device and wireless communication can include any of a numberof applicable wireless networking protocols including Bluetooth,Bluetooth Low Energy (BTLE), Wi-Fi or others. Local computer system 170can communicate via communications path 143 with a network 190 similarto how reader device 120 can communicate via a communications path 142with network 190, by wired or wireless technique as describedpreviously. Network 190 can be any of a number of networks, such asprivate networks and public networks, local area or wide area networks,and so forth. A trusted computer system 180 can include a server and canprovide authentication services and secured data storage and cancommunicate via communications path 144 with network 190 by wired orwireless technique.

Exemplary Reader Device

FIG. 2A is a block diagram depicting an example embodiment of a readerdevice configured as a smartphone. Here, reader device 120 can include adisplay 122, input component 121, and a processing core 206 including acommunications processor 222 coupled with memory 223 and an applicationsprocessor 224 coupled with memory 225. Also included can be separatememory 230, RF transceiver 228 with antenna 229, and power supply 226with power management module 238. Further included can be amulti-functional transceiver 232 which can communicate over Wi-Fi, NFC,Bluetooth, BTLE, and GPS with an antenna 234. As understood by one ofskill in the art, these components are electrically and communicativelycoupled in a manner to make a functional device.

Exemplary Sensor Control Devices

FIGS. 2B and 2C are block diagrams depicting example embodiments ofsensor control device 102 having analyte sensor 104 and sensorelectronics 160 (including analyte monitoring circuitry) that can havethe majority of the processing capability for rendering end-result datasuitable for display to the user. In FIG. 2B, a single semiconductorchip 161 is depicted that can be a custom application specificintegrated circuit (ASIC). Shown within ASIC 161 are certain high-levelfunctional units, including an analog front end (AFE) 162, powermanagement (or control) circuitry 164, processor 166, and communicationcircuitry 168 (which can be implemented as a transmitter, receiver,transceiver, passive circuit, or otherwise according to thecommunication protocol). In this embodiment, both AFE 162 and processor166 are used as analyte monitoring circuitry, but in other embodimentseither circuit can perform the analyte monitoring function. Processor166 can include one or more processors, microprocessors, controllers,and/or microcontrollers, each of which can be a discrete chip ordistributed amongst (and a portion of) a number of different chips.

A memory 163 is also included within ASIC 161 and can be shared by thevarious functional units present within ASIC 161, or can be distributedamongst two or more of them. Memory 163 can also be a separate chip.Memory 163 can be volatile and/or non-volatile memory. In thisembodiment, ASIC 161 is coupled with power source 170, which can be acoin cell battery, or the like. AFE 162 interfaces with in vivo analytesensor 104 and receives measurement data therefrom and outputs the datato processor 166 in digital form, which in turn processes the data toarrive at the end-result glucose discrete and trend values, etc. Thisdata can then be provided to communication circuitry 168 for sending, byway of antenna 171, to reader device 120 (not shown), for example, whereminimal further processing is needed by the resident softwareapplication to display the data.

FIG. 2C is similar to FIG. 2B but instead includes two discretesemiconductor chips 162 and 174, which can be packaged together orseparately. Here, AFE 162 is resident on ASIC 161. Processor 166 isintegrated with power management circuitry 164 and communicationcircuitry 168 on chip 174. AFE 162 includes memory 163 and chip 174includes memory 165, which can be isolated or distributed within. In oneexample embodiment, AFE 162 is combined with power management circuitry164 and processor 166 on one chip, while communication circuitry 168 ison a separate chip. In another example embodiment, both AFE 162 andcommunication circuitry 168 are on one chip, and processor 166 and powermanagement circuitry 164 are on another chip. It should be noted thatother chip combinations are possible, including three or more chips,each bearing responsibility for the separate functions described, orsharing one or more functions for fail-safe redundancy.

Exemplary Assembly Processes for Sensor Control Devices

The components of sensor control device 102 can be acquired by a user inmultiple packages requiring final assembly by the user before deliveryto an appropriate user location. FIGS. 3A-3D depict an exampleembodiment of an assembly process for sensor control device 102 by auser, including preparation of separate components before coupling thecomponents in order to ready the sensor for delivery. FIGS. 3E-3F depictan example embodiment of delivery of sensor control device 102 to anappropriate user location by selecting the appropriate delivery locationand applying device 102 to the location.

FIG. 3A is a proximal perspective view depicting an example embodimentof a user preparing a container 810, configured here as a tray (althoughother packages can be used), for an assembly process. The user canaccomplish this preparation by removing lid 812 from tray 810 to exposeplatform 808, for instance by peeling a non-adhered portion of lid 812away from tray 810 such that adhered portions of lid 812 are removed.Removal of lid 812 can be appropriate in various embodiments so long asplatform 808 is adequately exposed within tray 810. Lid 812 can then beplaced aside.

FIG. 3B is a side view depicting an example embodiment of a userpreparing an applicator device 150 for assembly. Applicator device 150can be provided in a sterile package sealed by a cap 708. Preparation ofapplicator device 150 can include uncoupling housing 702 from cap 708 toexpose sheath 704 (FIG. 3C). This can be accomplished by unscrewing (orotherwise uncoupling) cap 708 from housing 702. Cap 708 can then beplaced aside.

FIG. 3C is a proximal perspective view depicting an example embodimentof a user inserting an applicator device 150 into a tray 810 during anassembly. Initially, the user can insert sheath 704 into platform 808inside tray 810 after aligning housing orienting feature 1302 (or slotor recess) and tray orienting feature 924 (an abutment or detent).Inserting sheath 704 into platform 808 temporarily unlocks sheath 704relative to housing 702 and also temporarily unlocks platform 808relative to tray 810. At this stage, removal of applicator device 150from tray 810 will result in the same state prior to initial insertionof applicator device 150 into tray 810 (i.e., the process can bereversed or aborted at this point and then repeated withoutconsequence).

Sheath 704 can maintain position within platform 808 with respect tohousing 702 while housing 702 is distally advanced, coupling withplatform 808 to distally advance platform 808 with respect to tray 810.This step unlocks and collapses platform 808 within tray 810. Sheath 704can contact and disengage locking features (not shown) within tray 810that unlock sheath 704 with respect to housing 702 and prevent sheath704 from moving (relatively) while housing 702 continues to distallyadvance platform 808. At the end of advancement of housing 702 andplatform 808, sheath 704 is permanently unlocked relative to housing702. A sharp and sensor (not shown) within tray 810 can be coupled withan electronics housing (not shown) within housing 702 at the end of thedistal advancement of housing 702. Operation and interaction of theapplicator device 150 and tray 810 are further described below.

FIG. 3D is a proximal perspective view depicting an example embodimentof a user removing an applicator device 150 from a tray 810 during anassembly. A user can remove applicator 150 from tray 810 by proximallyadvancing housing 702 with respect to tray 810 or other motions havingthe same end effect of uncoupling applicator 150 and tray 810. Theapplicator device 150 is removed with sensor control device 102 (notshown) fully assembled (sharp, sensor, electronics) therein andpositioned for delivery.

FIG. 3E is a proximal perspective view depicting an example embodimentof a patient applying sensor control device 102 using applicator device150 to a target area of skin, for instance, on an abdomen or otherappropriate location. Advancing housing 702 distally collapses sheath704 within housing 702 and applies the sensor to the target locationsuch that an adhesive layer on the bottom side of sensor control device102 adheres to the skin. The sharp is automatically retracted whenhousing 702 is fully advanced, while the sensor (not shown) is left inposition to measure analyte levels.

FIG. 3F is a proximal perspective view depicting an example embodimentof a patient with sensor control device 102 in an applied position. Theuser can then remove applicator 150 from the application site.

System 100, described with respect to FIGS. 3A-3F and elsewhere herein,can provide a reduced or eliminated chance of accidental breakage,permanent deformation, or incorrect assembly of applicator componentscompared to prior art systems. Since applicator housing 702 directlyengages platform 808 while sheath 704 unlocks, rather than indirectengagement via sheath 704, relative angularity between sheath 704 andhousing 702 will not result in breakage or permanent deformation of thearms or other components. The potential for relatively high forces (suchas in conventional devices) during assembly will be reduced, which inturn reduces the chance of unsuccessful user assembly.

Exemplary Sensor Applicator Devices

FIG. 4A is a side view depicting an example embodiment of an applicatordevice 150 coupled with screw cap 708. This is an example of howapplicator 150 is shipped to and received by a user, prior to assemblyby the user with a sensor. FIG. 4B is a side perspective view depictingapplicator 150 and cap 708 after being decoupled. FIG. 4C is aperspective view depicting an example embodiment of a distal end of anapplicator device 150 with electronics housing 706 and adhesive patch105 removed from the position they would have retained within sensorcarrier 710 of sheath 704, when cap 708 is in place.

Referring to FIG. 4D-G for purpose of illustration and not limitation,the applicator device 20150 can be provided to a user as a singleintegrated assembly. FIGS. 4D and 4E provide perspective top and bottomviews, respectively, of the applicator device 20150, FIG. 4F provides anexploded view of the applicator device 20150 and FIG. 4G provides a sidecut-away view. The perspective views illustrate how applicator 20150 isshipped to and received by a user. The exploded and cut-away viewsillustrate the components of the applicator device 20150. The applicatordevice 20150 can include a housing 20702, gasket 20701, sheath 20704,sharp carrier 201102, spring 205612, sensor carrier 20710 (also referredto as a “puck carrier”), sharp hub 205014, sensor control device (alsoreferred to as a “puck”) 20102, adhesive patch 20105, desiccant 20502,cap 20708, serial label 20709, and tamper evidence feature 20712. Asreceived by a user, only the housing 20702, cap 20708, tamper evidencefeature 20712, and label 20709 are visible. The tamper evidence feature20712 can be, for example, a sticker coupled to each of the housing20702 and the cap 20708, and tamper evidence feature 20712 can bedamaged, for example, irreparably, by uncoupling housing 20702 and cap20708, thereby indicating to a user that the housing 20702 and cap 20708have been previously uncoupled. These features are described in greaterdetail below.

Exemplary Tray and Sensor Module Assembly

FIG. 5 is a proximal perspective view depicting an example embodiment ofa tray 810 with sterilization lid 812 removably coupled thereto, whichmay be representative of how the package is shipped to and received by auser prior to assembly.

FIG. 6A is a proximal perspective cutaway view depicting sensor deliverycomponents within tray 810. Platform 808 is slidably coupled within tray810. Desiccant 502 is stationary with respect to tray 810. Sensor module504 is mounted within tray 810.

FIG. 6B is a proximal perspective view depicting sensor module 504 ingreater detail. Here, retention arm extensions 1834 of platform 808releasably secure sensor module 504 in position. Module 2200 is coupledwith connector 2300, sharp module 2500 and sensor (not shown) such thatduring assembly they can be removed together as sensor module 504.

Exemplary Applicator Housings and Caps

FIG. 7A is side view depicting an example embodiment of the applicatorhousing 702 that can include an internal cavity with support structuresfor applicator function. A user can push housing 702 in a distaldirection to activate the applicator assembly process and then also tocause delivery of sensor control device 102, after which the cavity ofhousing 702 can act as a receptacle for a sharp. In the exampleembodiment, various features are shown including housing orientingfeature 1302 for orienting the device during assembly and use. Tamperring groove 1304 can be a recess located around an outer circumferenceof housing 702, distal to a tamper ring protector 1314 and proximal to atamper ring retainer 1306. Tamper ring groove 1304 can retain a tamperring so users can identify whether the device has been tampered with orotherwise used. Housing threads 1310 can secure housing 702 tocomplimentary threads on cap 708 (FIGS. 4A and 4B) by aligning withcomplimentary cap threads and rotating in a clockwise orcounterclockwise direction. A side grip zone 1316 of housing 702 canprovide an exterior surface location where a user can grip housing 702in order to use it. Grip overhang 1318 is a slightly raised ridge withrespect to side grip zone 1316 which can aid in ease of removal ofhousing 702 from cap 708. A shark tooth 1320 can be a raised sectionwith a flat side located on a clockwise edge to shear off a tamper ring(not shown), and hold tamper ring in place after a user has unscrewedcap 708 and housing 702. In the example embodiment four shark teeth 1320are used, although more or less can be used as desired.

FIG. 7B is a perspective view depicting a distal end of housing 702.Here, three housing guide structures (or “guide ribs”) 1321 are locatedat 120 degree angles with respect to each other and at 60 degree angleswith respect to locking structures (or “locking ribs”) 1340, of whichthere are also three at 120 degree angles with respect to each other.Other angular orientations, either symmetric or asymmetric, can be used,as well as any number of one or more structures 1321 and 1340. Here,each structure 1321 and 1340 is configured as a planar rib, althoughother shapes can be used. Each guide rib 1321 includes a guide edge(also called a “sheath guide rail”) 1326 that can pass along a surfaceof sheath 704 (e.g., guide rail 1418 described with respect to FIG. 8A).An insertion hard stop 1322 can be a flat, distally facing surface ofhousing guide rib 1321 located near a proximal end of housing guide rib1321. Insertion hard stop 1322 provides a surface for a sensor carriertravel limiter face 1420 of a sheath 704 (FIG. 8B) to abut during use,preventing sensor carrier travel limiter face 1420 from moving anyfurther in a proximal direction. A carrier interface post 1327 passesthrough an aperture 1510 (FIG. 9A) of sensor carrier 710 during anassembly. A sensor carrier interface 1328 can be a rounded, distallyfacing surface of housing guide ribs 1321 which interfaces with sensorcarrier 710.

FIG. 7C is a side cross-section depicting an example embodiment of ahousing. In the example embodiment, side cross-sectional profiles ofhousing guide rib 1321 and locking rib 1340 are shown. Locking rib 1340includes sheath snap lead-in feature 1330 near a distal end of lockingrib 1340 which flares outward from central axis 1346 of housing 702distally. Each sheath snap lead-in feature 1330 causes detent snap round1404 of detent snap 1402 of sheath 704 as shown in FIG. 8C to bendinward toward central axis 1346 as sheath 704 moves towards the proximalend of housing 702. Once past a distal point of sheath snap lead-infeature 1330, detent snap 1402 of sheath 704 is locked into place inlocked groove 1332. As such, detent snap 1402 cannot be easily moved ina distal direction due to a surface with a near perpendicular plane tocentral axis 1346, shown as detent snap flat 1406 in FIG. 8C.

As housing 702 moves further in a distal direction toward the skinsurface, and as sheath 704 advances toward the proximal end of housing702, detent snaps 1402 shift into the unlocked grooves 1334, andapplicator 150 is in an “armed” position, ready for use. When the userfurther applies force to the proximal end of housing 702, while sheath704 is pressed against the skin, detent snap 1402 passes over firingdetent 1344. This begins a firing sequence (as described, for example,with respect to FIGS. 12A-12D) due to release of stored energy in thedeflected detent snaps 1402, which travel in a proximal directionrelative to the skin surface, toward sheath stopping ramp 1338 which isslightly flared outward with respect to central axis 1346 and slowssheath 704 movement during the firing sequence. The next grooveencountered by detent snap 1402 after unlocked groove 1334 is finallockout groove 1336 which detent snap 1402 enters at the end of thestroke or pushing sequence performed by the user. Final lockout recess1336 can be a proximally-facing surface that is perpendicular to centralaxis 1346 which, after detent snap 1402 passes, engages a detent snapflat 1406 and prevents reuse of the device by securely holding sheath704 in place with respect to housing 702. Insertion hard stop 1322 ofhousing guide rib 1321 prevents sheath 704 from advancing proximallywith respect to housing 702 by engaging sensor carrier travel limiterface 1420.

FIGS. 7D and 7E are close-up side views of an example embodiment oflocking rib 1340 of applicator housing 702, as detent snap 1402 ofsheath 704 moves toward the proximal end of housing 702. FIG. 7D showssheath 704 in a “locked” state, in which detent round 1404 of detentsnap 1402 has already passed over sheath snap lead-in feature 1330 andis positioned in locked groove 1332 of locking rib 1340. As force isapplied to the proximal end of housing 702, detent round 1404 isadvanced proximally into unlocked groove 1334, placing applicator 150into an “armed” position. When force is further applied to the proximalend of housing 702, applicator 150 is “fired,” as detent round 1404 isadvanced proximally from the unlocked groove 1334 and passes over firingdetent 1344. Thereafter, sheath 704 is further advanced proximally suchthat detent round 1404 is slidably advanced over firing surface 1337, asshown in FIG. 7E. In this embodiment, firing surface 1337 issubstantially parallel to central axis 1346. As sheath 704 continues toadvance proximally, detent round 1404 reaches sheath stopping ramp 1338which slows the movement of sheath 704. Upon detent round 1404 reachingfinal lockout recess 1336, detent snap flat 1406 (not shown) is engagedand securely holds sheath 704 in place with respect to housing 702.

FIGS. 7F and 7G are close-up side views of an alternative embodiment oflocking rib 2340 that is designed to improve the firing velocity of thesharp from the sensor applicator. Here, locking rib 2340 includes aninward detent ramp 2335 to reduce friction between sheath 704 andhousing 2702 during firing. Locking rib 2340 also includes a sheathstopping ramp 2338 at the proximal end of firing surface 2337. In FIG.7F, sheath 704 is initially shown in a “locked” state, in which detentround 1404 of detent snap 1402 has already passed over sheath snaplead-in feature 2330, and is positioned in locked groove 2332. As forceis applied to the proximal end of housing 2702, detent round 1404 isadvanced into unlocked groove 2334, placing applicator 150 into the“armed” position. When force is further applied to the proximal end ofhousing 2702, applicator 150 is “fired,” as detent round 1404 passesover firing detent 2344.

As shown in FIG. 7G, detent round 1404 then advances toward the proximalend of housing 2702 in a “free flight” state, in which detent round 1404passes over inward detent ramp 2335. While advancing proximally in the“free flight” state, detent round 1404 can be in non-continuous, or haveno contact with, inward detent ramp 2335 and firing surface 2337. Inthis regard, detent round 1404 can be easily and quickly advanced, asthere is little to no frictional force between detent round 1404 andinward detent ramp 2335 and firing surface 2337, and as such, improvesupon the firing velocity of the sharp from the applicator. Sheathstopping ramp 2338, which is positioned proximally further along thelocking rib 2340 relative to the embodiment shown in FIGS. 7D and 7E,provides an edge portion to frictionally engage the detent round 1404and slow the movement of sheath 704. The sheath stopping ramp 2338 canhave a sloped shape and provide for increasing frictional contact as thedetent round 1404 advances in a proximal direction. Finally, upon detentround 1404 reaching final lockout recess 2336, detent snap flat 1406(not shown) is engaged and securely holds sheath 704 in place withrespect to housing 2702. Lockout recess 2336 prevents detent round 1404and sheath 704 from backwards, or distal movement. This embodimentreflects a higher firing velocity relative to the embodiment depicted inFIGS. 7D and 7E, which also assists in prevention of a prematurewithdrawal of sharp.

FIG. 7H is a close-up side view of an alternative embodiment of lockingrib 6340 designed to maintain a downward force on sheath 6704 duringfiring which, in turn, can prevent sheath 6704 from unwanted movementduring the sensor insertion process. Here, sheath 6704 is shown in a“locked” state, in which detent round 6404 of detent snap 6402 ispositioned in locked groove 6332. As force is applied to the proximalend of housing 6702, detent round 6404 is advanced into unlocked groove6334, placing applicator in the “armed” position. When force is furtherapplied to the proximal end of housing 6702, applicator is “fired,” anddetent round 6404 advances over sloped firing surface 6338 toward theproximal end of housing 6702. Sloped firing surface 6338 can be angledtoward central axis 1346 such that the resulting downward force uponsheath 6704 increases as detent round 6404 advances in a proximaldirection. In the depicted embodiment, detent round 6404 is incontinuous contact with sloped firing surface 6338. Lockout recess 6336prevents detent round 6404 and sheath 6704 from backwards, or distalmovement. This embodiment reflects a slower firing velocity relative tothe previously described embodiments, and can be used, for example, withthe motion-actuated sharp retraction process that is described withrespect to FIGS. 14A-14C and 15A-15B.

FIG. 7I is a close-up side view of still another alternative embodimentof locking rib 7340, also designed to maintain a downward force onsheath 6704 during firing which, in turn, can prevent sheath 6704 fromunwanted movement during a sensor insertion process. Here, sheath 6704is shown in a “fired” state, in which detent round 6404 of detent snap6402 is positioned in a two-way lockout recess 7336. Upon detent round6404 advancing into two-way lockout recess 7336, sheath 6704 can beprevented from further movement in either a proximal or distaldirection. This can reduce unwanted movement of sheath 6704 during thesensor insertion process. Furthermore, in some embodiments, as describedwith respect to FIGS. 14A-14C and 15A-15B, two-way lockout recess 7336can provide for the immobilization of sheath 6704 during amotion-actuated sharp retraction process. As can be seen in FIG. 7I,sloped firing surface 7338 is angled toward central axis 1346 such thata resulting downward force upon sheath 6704 increases as detent round6404 advances in a proximal direction. In the depicted embodiment,detent round 6404 is in continuous contact with sloped firing surface7338. This embodiment reflects a slower firing velocity and can be used,for example, with the motion-actuated sharp retraction process that isdescribed with respect to FIGS. 14A-14C and 15A-15B.

Referring to FIGS. 7J-7L, for purpose of illustration and notlimitation, a housing 20702 in accordance with the disclosed subjectmatter is provided. Housing 20702 can be made of cyclic olefincopolymer, or other suitable materials, such as PolyCarbonate or highdensity poly ethylene (HDPE). Housing 20702 can include one or more ofthe features described herein with regard to housings, wherein similarfeatures can operate as described herein. For example, housing 20702 caninclude a grip overhang 20702A that can enable a user to securely griphousing 20702. The housing 20702 can have additional grip overhangs20702A, for example, two grip overhands 20702A on opposite sides of thehousing 20702. The housing 20702 can include a side grip zone 20702Bdisposed below the grip overhand 20702A. The side grip zone 20702B canbe textured for improved gripping by a user. The housing 20702 can haveadditional side grip zones 20702B, for example, two side grip zones20702B on opposite sides of the housing 20702, each disposed below agrip overhang 20702A.

The housing 20702 can include a housing skirt 20702C, which can providea surface for tamper evidence feature 20712. The housing skirt 20702Ccan be supported by a plurality of skirt stiffening ribs 20702D. Theskirt stiffening ribs 20702D can provide support for the housing skirt20702C and can help protect the applicator device 20150 during a shockevent, such as a drop. Additionally, the skirt stiffening ribs 20702Dcan be used to support the housing 20702 during manufacturing. Thehousing skirt 20702C and skirt stiffening ribs 20702D can providestiffness against forces due to gasket compression, and can helpmaintain gasket 20701 compression through shelf life. The housing 20702can include a gasket retention ring 20702E and a plurality of gasketretention pockets 20702F, which can hold the gasket 20701 relative thehousing 20702. For example, the gasket retention ring 20702E can preventlateral and/or axial movement of the gasket 20701, and the gasketretention pockets 20702E can prevent rotation of the gasket 20701. Thehousing 20702 can include a plurality of gasket retention pockets, forexample, 14 gasket retention pockets 20702E. Gasket sealing face 20702Nthat can seal against the gasket 20701. Housing 20702 can additionallyor alternatively have an applicator cap sealing lip 20702U that caninterface with the cap 20708, as described in greater detail below.Housing 20702 can have inner surface 20702T that can receive the sheath20704.

Housing 20702 can include threads 20702G configure to engage withthreads 20708D disposed on cap 20708. The threads can include radiallimiting features 20702H, which can limit radial deformation of the cap20702 (e.g., 20708D, 20708F, and 20708G) during a shock event, such as adrop. Housing 20702 can include a plurality of radial limiting features20702H, for example, 6 radial limiting features 20702H. The radiallimiting features 20702H can be protrusions from the housing and canclose a gap with the threads 20708D disposed on cap 20708. This canlimit oval deformation of the cap 20708 during a shock event, such as adrop. Preventing oval deformation of cap 20708 can, in turn, ensure thatlock arms 20704J of sheath 20704 stay locked between the cap 20708 andthe sensor carrier 20710 (e.g., lock ledges 20710N) to limit movement ofthe sheath 20704 prior to removing cap 20708 (as described in greaterdetail below). Housing 20702 can further include a clearance notch20702I for clearance of the sheath arms during firing.

The interior of housing 20702 can include a plurality of sensor carrierattachment features for receiving, aligning, and limiting movement ofthe sensor carrier 20710. For example, housing 20703 can include sheathguide rails 20702J, which can help to align and guide sheath 20704 asthe sheath 20704 moves relative the housing 20702. Housing 20702 caninclude sensor carrier attach slots 20702K, which can engage and holdthe sensor carrier 20710, and sensor carrier hard stops 20702L, that canlimit axial movement of the sensor carrier 20710 relative the housing20702. Housing 20702 can include sensor carrier biasing feature 20702Mthat can remove slop between the sensor carrier 20710 and the housing20702 after assembly and sensor carrier radial limiting feature 20702Othat can keep the sensor carrier radially aligned relative the housing20702. Flat horizontal faces between sensor carrier attach slots 20702Kand sensor carrier radial limiting feature 20702O can be used to stopthe sheath 20704 at the end of a stroke. Corresponding features on thesheath 20704 can interact with these faces. The sensor carrier biasingfeature 20702M can further limit rotation of the sensor carrier 20710relative the housing 20702. Housing 20702 can include one or more ofeach of the sheath guide rails 20702J, sensor carrier attach slots20702K, sensor carrier hard stops 20702L, sensor carrier radial limitingfeature 20702O, and sensor carrier biasing feature 20702M, for example,three of each.

The interior of housing 20702 can further include a plurality sheathribs 20702S for engaging the sheath 20704 for insertion, as describedherein. Housing 20702 can include one or more of sheath ribs 20702S, forexample, three. Each sheath rib 20702S can include a sheath snap lead infeature 20702P configured to initially lead in the detent snap 20704A ofsheath 20704 into the correct location. The housing 20702 can include afiring detent 20702Q. After the detent snap 20704A of sheath 20704passes the firing detent 20702Q, the firing sequence can be initiated,and the sheath 20704 can travel toward the sheath stopping ramp 20702R.The sheath stopping ramp 20702 can slow the sheath 20704 at the end offiring.

Referring to FIGS. 7M-7U for purpose of illustration, an exemplary cap20708 is provided. Cap 20708 can include one or more of the featuresdescribed herein with regard to caps, wherein similar features canoperate as described herein. Cap 20708 can be made of high densitypolyethylene (HDPE) or any other suitable materials, such asPolyPropylene or low-density polyethylene (LDPE). Cap 20708 can includea label surface 20708A configured to receive label 20709. Cap 20708 caninclude ribs 20708B which can provide strength and provide an improvedgripping surface for a user. The cap 20708 can include tamper label ring20708C, which can receive the tamper evidence feature 20712. The cap20708 can also include a gasket sealing surface 20708G, configured toengage gasket 20701.

Internally, cap 20708 can include threads 20708D, which can engagethreads 20702G disposed on the housing 20702. Cap 20708 can also includeseal interface 20708E which can be configured to receive the applicatorcap sealing lip 20702U to create a seal between the housing 20702 andthe cap 20708.

FIGS. 7P-S show an enlarged cross-sectional side view of the interfacebetween housing 20702 and cap 20708. As illustrated, applicator capsealing lip 20702U of housing 20702 includes a first axial extension2002 a and seal interface 20708E of cap 20708 provides a cavity 2002 dmatable with the first axial extension 2002 a. In the illustratedembodiment, the diameter of cavity 2002 d formed from second axialextension 2002 b and third axial extension 2002 c of the cap 20708 issized to receive the diameter of first axial extension 2002 a of housing20702 within cavity 2002 d. For example, as shown in FIG. 7R, axialextension 2002 a can have thickness D1 at height H1, as measured fromdistal edge of axial extension 2002 a. Similarly, second axial extension2002 c can have a thickness D5 at height H3, as measured from proximaledge of cap 20708; cavity 2002 d can have a thickness D2, D3, and D4 atheights H2, H3, and H4, respectively, as measured from proximal edge ofcap 20708. In certain embodiments, D1 can measure 1 mm with a toleranceof +/−0.03 mm, D2, D3, D4 can have any suitable dimensions, H1 canmeasure 1.66 mm with a tolerance of +/−0.1 mm, H2 can measure 8.25 mmwith a tolerance of +/−0.1 mm, H3 can measure 9.25 mm with a toleranceof +/−0.1 mm, H4 can measure 9.75 mm with a tolerance of +/−0.1 mm. Inother embodiments, however, the reverse can be employed, where thediameter of first axial extension 2002 a can be sized to receive thediameter of the second axial extension 2002 b, without departing fromthe scope of the disclosure.

In each embodiment, two radial seals 2004, 2006 can be defined orotherwise provided at the interface between first and second axialextensions 2002 a, b and radial seals 2004 and 2006 can help preventmigration of fluids or contaminants across the interface in either axialdirection. Moreover, the dual radial seals described herein canaccommodate tolerance and thermal variations combined with stressrelaxation via a redundant sealing strategy. In the illustratedembodiment, dual radial seals 2004, 2006 utilize a “wedge” effect foreffective sealing between first axial extension 2002 a and second axialextension 2002 b.

Cap 20708 can include one or more sets of ribs 20708F (see FIG. 7N), forexample, two sets of ribs 20708F, wherein ribs 20708F can comprise crushribs. The crush ribs 20708F can be configured to engage the edge 20704Nof lock arm 20704J during a shock event, for example a drop, asdescribed in greater detail below (see e.g., FIG. 8N). According to manyembodiments, edge 20704N can be a sharp edge.

In accordance with the disclosed subject matter, Cap 20708 can includeone or more desiccant retention clips 20708H to retain the desiccant20502 in the cap 20708 and limit rotation of the desiccant 20502. Cap20708 can include a ratchet 207081 to engage the sensor cap and removethe sensor cap when the cap 20708 is removed from the housing 20702, asdescribed in greater detail below. Cap 20708 can include a plurality ofribs 20708J to provide strength.

Referring to FIGS. 7T and 7U for purpose of illustration and notlimitation, in accordance with the disclosed subject matter, cap 20708can include one or more surfaces to engage other elements in theapplicator device 20150 to provide support or limit movement in the caseof a shock event, for example, a drop. For example, the cap can includea sheath support surface 20708K, configured to support the sheath 20704during a shock event. The sheath support surface 20708K can limit distalmovement of the sheath 20704 during a shock event. This can lead to lessstress on the sensor carrier 20710 and the sensor control device 20102and can reduce the risk of the sensor control device 20102 dislodgingfrom the sensor carrier 20710. Additionally or alternatively, the cap20708 can include a raised ridge 20708L. The raised ridge 20708L caninterface with a plug, such as an elastomeric plug 9130A (which can becoupled to, e.g., a sensor cap or a desiccant cap). The raised ridge20708L can thereby also support the sharp carrier 1102, sensor carrier20710, sensor control device 20102, and accordingly, can preventdislodging of the sensor control device 20102 from the sensor carrier20710 during a shock event. Furthermore, additional support on theelastomeric plug 9130A and other features can increase the stress onvarious seals in the applicator device 20150, and thereby improve theseals prior to removing the cap 20708 from the housing.

Exemplary Applicator Sheaths

FIGS. 8A and 8B are a side view and perspective view, respectively,depicting an example embodiment of sheath 704. In this exampleembodiment, sheath 704 can stage sensor control device 102 above auser's skin surface prior to application. Sheath 704 can also containfeatures that help retain a sharp in a position for proper applicationof a sensor, determine the force required for sensor application, andguide sheath 704 relative to housing 702 during application. Detentsnaps 1402 are near a proximal end of sheath 704, described further withrespect to FIG. 8C below. Sheath 704 can have a generally cylindricalcross section with a first radius in a proximal section (closer to topof figure) that is shorter than a second radius in a distal section(closer to bottom of figure). Also shown are a plurality of detentclearances 1410, three in the example embodiment. Sheath 704 can includeone or more detent clearances 1410, each of which can be a cutout withroom for sheath snap lead-in feature 1330 to pass distally into until adistal surface of locking rib 1340 contacts a proximal surface of detentclearance 1410.

Guide rails 1418 are disposed between sensor carrier traveler limiterface 1420 at a proximal end of sheath 704 and a cutout around lock arms1412. Each guide rail 1418 can be a channel between two ridges where theguide edge 1326 of housing guide rib 1321 can slide distally withrespect to sheath 704.

Lock arms 1412 are disposed near a distal end of sheath 704 and caninclude an attached distal end and a free proximal end, which caninclude lock arm interface 1416. Lock arms 1412 can lock sensor carrier710 to sheath 704 when lock arm interface 1416 of lock arms 1412 engagelock interface 1502 of sensor carrier 710. Lock arm strengthening ribs1414 can be disposed near a central location of each lock arm 1412 andcan act as a strengthening point for an otherwise weak point of eachlock arm 1412 to prevent lock arm 1412 from bending excessively orbreaking.

Detent snap stiffening features 1422 can be located along the distalsection of detent snaps 1402 and can provide reinforcement to detentsnaps 1402. Alignment notch 1424 can be a cutout near the distal end ofsheath 704, which provides an opening for user alignment with sheathorientation feature of platform 808. Stiffening ribs 1426 can includebuttresses, that are triangularly shaped here, which provide support fordetent base 1436. Housing guide rail clearance 1428 can be a cutout fora distal surface of housing guide rib 1321 to slide during use.

FIG. 8C is a close-up perspective view depicting an example embodimentof detent snap 1402 of sheath 704. Detent snap 1402 can include a detentsnap bridge 1408 located near or at its proximal end. Detent snap 1402can also include a detent snap flat 1406 on a distal side of detent snapbridge 1408. An outer surface of detent snap bridge 1408 can includedetent snap rounds 1404 which are rounded surfaces that allow for easiermovement of detent snap bridge 1408 across interior surfaces of housing702 such as, for example, locking rib 1340.

FIG. 8D is a side view depicting an example embodiment of sheath 704.Here, alignment notch 1424 can be relatively close to detent clearance1410. Detent clearance 1410 is in a relatively proximal location ondistal portion of sheath 704.

FIG. 8E is an end view depicting an example embodiment of a proximal endof sheath 704. Here, a back wall for guide rails 1446 can provide achannel to slidably couple with housing guide rib 1321 of housing 702.Sheath rotation limiter 1448 can be notches which reduce or preventrotation of the sheath 704.

FIGS. 8F-8H are perspective views of an alternative example embodimentof sheath 6704 in various stages of assembly with other components ofthe applicator. As shown in FIG. 8F, sheath 6704 can have many of thesame features as sheath 704, previously described with respect to FIGS.8A-8C. Sheath 6704, for example, can include one or more detent snaps6404 having one or more detent rounds 6402 attached thereto. Sheath6704, however, can be shorter in overall length as compared to sheath702. In addition, sheath 6704 can include one or more inner sheath ribs6425 disposed on the inner surface of sheath 6704, and which protrude inan inward direction towards the central axis of sheath 6704.

Turning to FIG. 8G, sheath 6704 is shown in perspective view in a stageof assembly with applicator housing 6702 and sensor carrier 6710. One ormore inner sheath ribs 6425 of sheath 6704 can interface with one ormore corresponding rib notches 6519 in sensor carrier 6710. The fittedinterface between corresponding ribs 6425 and notches 6519 can helpmaintain axial alignment of the sheath 6704 and sensor carrier 6710during the sensor insertion process. Furthermore, the interface betweenribs 6425 and notches 6519 can reduce lateral and rotational movementbetween the applicator components, which can, in turn, reduce the chanceof improper sensor insertion.

Turning to FIG. 8H, sheath 6704 is shown in perspective view in a stageof assembly with applicator housing 6702 and sensor electronics housing706, which has been inserted into sensor carrier 6710. Inner sheath ribs6425 are also shown.

It should be noted that although six inner sheath ribs 6425 and sixcorresponding rib notches 6519 are depicted, any number of ribs andnotches are fully within the scope of the present disclosure. Moreover,while ribs 6425 are depicted with a rounded surface edge, in otherembodiments, ribs 6425 can have a rectangular or triangular shape, andrib notches 6519 can have a corresponding receiving shape forinterfacing with ribs 6425. In addition, although ribs 6425 are depictedas being disposed on an inner circumferential surface of sheath 6704,ribs 6425 can also be disposed on any other surface of sheath 6704, orportion thereof, that comes into contact with sensor carrier 6710.

Referring to FIGS. 8I-8O, for purpose of illustration and notlimitation, a sheath 20704 is provide, in accordance with the disclosedsubject matter. Sheath 20704 can be made of Delrin or other suitablematerials, for example, other low friction polymers. Sheath 20704 caninclude one or more of the features described herein with regard tosheaths, wherein similar features can operate as described herein. Forexample, sheath 20704 can include detent snaps 20704A having a freeproximal end, configured to engage the sheath ribs 20702S during firing.FIG. 8J shows a close up of the free proximal end of detent snap 20704A.The detent snaps 20704A can include a round portion 20704B, forengagement with the sheath ribs 20702S and a flat portion 20704C forfinal lockout on housing 20704 after use. The round portion 20704B caninclude a parting line mismatch 20704D that can prevent a force spikeduring firing. The detent snaps 20704A can be coupled to the sheath20704 at an enlarged distal portion 20704E, which can provide support tothe detent snap 20704. Sheath 20704 can include a plurality of detentsnaps 20704A, for example, three. The sheath 20704 can include one ormore, for example, three, housing clearances 20704F, which can allow thesheath 20704 to clear the housing 20702 at the end of firing. Inaccordance with the disclosed subject matter, sheath 20704 can furtherinclude a plurality of stiffening ribs 20704P (e.g., six) which canstiffen the sheath 20704.

Sheath 20704 can include a plurality of guides 20704G for engaging thesheath guide rails 20702J of the housing 20702. Sheath 20704 can furtherinclude a slot 20704H including a stop 20704I at a distal end of theslot 20704H configured to engage the sheath guide rails 20702J of thesheath 20702 to limit further proximal movement of the sheath 20704relative the housing 20702 at the end of firing. Sheath 20704 can alsoinclude a clearance 20704T for clearing the sensor carrier biasingfeature 20702I disposed on the sheath guide rails 20702J of the housing20702.

In accordance with the disclosed subject matter, sheath 20704 caninclude lock arms 20704J. Lock arms 20704J can be configured to engagethe sensor carrier 20710 and limit movement of the sensor carrier 20710or sheath 20704 prior to firing. The lock arms 20704J can include a freeproximal end 20704K and an attached distal end 20704L. The free proximalend 20704K can include a lock arm interface 20704M disposed on an innersurface of the lock arm 20704J. The lock arm interface 20704M can engagea lock ledge 20710N on the sensor carrier 20710. For example, when cap20708 is coupled to housing 20702, the cap 20708 can urge the lock arm20704J inwardly, and can cause the lock arm interface 20704M to engagethe sensor carrier 20710. That is, the lock arms 20704J can wedgebetween the cap 20708 and the sensor carrier 20710. Accordingly, thelock arm 20704J can limit proximal movement of the sheath 20704 when thecap 20708 is coupled to the housing 20702. Such engagement can limitmovement of the sheath 20704 during a shock event, such as a drop. Thelock arm interface 20704M can have a triangle shape when viewed in sideview (e.g., FIG. 8N) and a “U” shape when viewed in top view (e.g., FIG.8K). The shape of the lock arm interface 20704M can provide benefitsduring manufacturing. For example, the shape of the lock arm interface20704M can allow the sheath 20704 to be force ejected from a mold duringmanufacturing of the sheath 20704. Force ejecting the sheath 20704 canallow for a more a simplified manufacture process, for example, using asimplified core/cavity design, and can eliminate additional partinglines or the use of complicated lifters and/or slides to create undercutfeatures in the plastic part. Parting lines can result in an unsmoothsurface which can catch on the sensor carrier 20710 during firing andcan result in potential spikes in firing force. Accordingly, using forceejection results in a simpler mold design facilitating a smoother lockarm interface 20704M and prevent potential spikes in firing force due toparting lines.

The proximal free end of the lock arm 20704J can further include an edge20704N (such as, e.g., a sharp edge) on an outer surface. The sharp edge20704N can be configured to engage ribs 20708F (which can comprise,e.g., crush ribs) disposed on the cap 20708 during a shock event. Thesharp edge 20704N can dig into the crush ribs 20708F and permanentlydeform the crush ribs 20708F, which can absorb energy during a shockevent, and prevent sheath 20704 collapse. The shape lock arm interface20704M can also be beneficial for drop protection. The ramp can forcethe lock arm 20704J to move radially as the sheath 20704 collapsedduring a drop. This can force the sharp edge 20704N to dig into thecrush ribs 20708F and can help to stop the sheath 20704 from collapsing.Sheath 20704 can include a plurality of lock arms 20704J, for example,two lock arms 20704J.

Additionally or alternatively, sheath 20704 can include rib 20704Uconfigured to engage a lock interface 20710F on a sensor retention arm20710B on the sensor carrier 20710. The rib 20704U can prevent thesensor retention arm 20710B from flexing outwardly, for example, duringa shock event, and therefore can prevent movement of the sensor controldevice 20102 during a shock event. Rib 20704U can have a height (i.e.,in the longitudinal direction) selected such that even if the sheath20704 moves proximally or distally during a shock event, the rib 20704Uwill continue to engage lock interface 20710F on a sensor retention arm20710B on the sensor carrier 20710 and prevent the sensor control device20102 from dislodging from the sensor carrier 20710.

The sheath 20704 can include a noise damper 207040. The noise damper207040 can be configured to engage the sharp carrier 201102 as the sharpcarrier 201102 is retracted to slow movement of the sharp carrier 201102and can thereby reduce noise produce by the sharp carrier 201102engaging the sheath 20704. In exemplary embodiments, the noise damper207040 includes an angled ramp extending from the inner surface ofsheath 20704, but other suitable configurations can be used.

In accordance with the disclosed subject matter, sheath 20704 caninclude a slot 20704Q configured to receive sharp carrier retentionfeature 20710L disposed on the sensor carrier 20710 and to therebypermit partial retraction of the sharp carrier 201102 during deployment(as described in greater detail below). The sheath 20704 can alsoinclude cap lead-in 20704R, alignment notch 20704S and skin interface20704T.

Exemplary Sensor Carriers

FIG. 9A is a proximal perspective view depicting an example embodimentof sensor carrier 710 that can retain sensor electronics withinapplicator 150. It can also retain sharp carrier 2102 with sharp module2500. In this example embodiment, sensor carrier 710 generally has ahollow round flat cylindrical shape, and can include one or moredeflectable sharp carrier lock arms 1524 (e.g., three) extendingproximally from a proximal surface surrounding a centrally locatedspring alignment ridge 1516 for maintaining alignment of spring 1104.Each lock arm 1524 has a detent or retention feature 1526 located at ornear its proximal end. Shock lock 1534 can be a tab located on an outercircumference of sensor carrier 710 extending outward and can locksensor carrier 710 for added safety prior to firing. Rotation limiter1506 can be a proximally extending relatively short protrusion on aproximal surface of sensor carrier 710 which limits rotation of carrier710. Sharp carrier lock arms 1524 can interface with sharp carrier 2102as described with reference to FIGS. 10A-10E below.

FIG. 9B is a distal perspective view of sensor carrier 710. Here, one ormore sensor electronics retention spring arms 1518 (e.g., three) arenormally biased towards the position shown and include a detent 1519that can pass over the distal surface of electronics housing 706 ofdevice 102 when housed within recess or cavity 1521. In certainembodiments, after sensor control device 102 has been adhered to theskin with applicator 150, the user pulls applicator 150 in a proximaldirection, i.e., away from the skin. The adhesive force retains sensorcontrol device 102 on the skin and overcomes the lateral force appliedby spring arms 1518. As a result, spring arms 1518 deflect radiallyoutwardly and disengage detents 1519 from sensor control device 102thereby releasing sensor control device 102 from applicator 150.

FIG. 9C is a perspective view of an alternative example embodiment ofsensor carrier 6710. As shown in FIG. 9C, sensor carrier 6710 can havemany of the same features as sensor carrier 710, previously describedwith respect to FIGS. 9A-9B. In addition, sensor carrier 6710 alsoincludes one or more notch ribs 6519 disposed along an outercircumferential surface. As best seen in FIGS. 8F-8H, notch ribs 6519are configured to interface with inner sheath ribs 6425 in order tomaintain axial alignment of the sheath and sensor carrier, and reducelateral and rotational movement between applicator components during thesensor insertion process.

Referring to FIGS. 9D and 9E, for purpose of illustration and notlimitation, an exemplary sensor carrier 20710 is provided. Sensorcarrier 20710 can include one or more of the features described hereinwith regard to sensor carriers, wherein similar features can operate asdescribed herein. For example, sensor carrier 20710 can include a base20710A and first and second retention arms 20710B. Each retention arm20710B can include a first end portion 20710C coupled to the base 20710Aand a free end portion 20710D. For example, each retention arm 20710Bcan be coupled to the base 20710A at a first half of the base 20710A andthe free end portion 20710D can extend toward a second half of the base20710A. Each retention arm 20710B can include a sensor retention feature20710E disposed on an inner surface of the sensor retention arm 20710B.The sensor retention feature 20710E can be disposed on the free endportion 20710D. The sensor retention feature 20710E can be configured toretain the sensor control device 20102 within the housing 20702. Theretention feature 20710E can include a conical surface and angularparting line, which can allow for release of the sensor control device20102 upon delivery. Each retention arm 20710 can include a lockinterface 20710F disposed on an outer surface of the retention arm20710B. The lock interface 20710F can engage rib 20704U on the sheath20704. As described hereinabove, the rib 20704U can prevent the sensorretention arm 20710B from flexing outwardly, for example, during a shockevent, and therefore can keep retention feature 20710E engaged with thesensor control device 20102, and thereby prevent movement of the sensorcontrol device 20102 during a shock event.

Sensor carrier 20710 can include a plurality of housing attachmentfeatures 20710F1. In some embodiments, for example, sensor carrier 20710can include three housing attachment features 20710F1. In otherembodiments, sensor carrier 20710 can include two, four, five, six, ormore housing attachment features 20710F1. The housing attachmentfeatures 20710F1 can be equally spaced on the sensor carrier 20710 andcan extend upwardly from a top surface of the sensor carrier 20710. Eachsensor housing attachment feature 20710F1 can include a housing snap20710G, housing locator feature 20710H, biasing feature 20710I, andhousing stop 20710J. The housing locator feature 20710H can axiallylocate the sensor carrier 20710 relative the housing 20702 when the twoare to be coupled together. The housing snap 20710G can engage thesensor carrier attach slots 20702K on the housing 20702 to couple thesensor carrier 20710 to the housing 20702. The biasing feature 20710Ican engage sensor carrier biasing feature 20702M on housing 20702configured to remove slop between the sensor carrier 20710 and thehousing 20702. Housing stop 20710J can locate the sensor carrier 20710axially relative to the housing 20702.

Sensor carrier 20710 can further include a plurality of sharp carrierlock arms 20710K, for example three sharp carrier lock arms 20710K. Thesharp carrier lock arms 20710K can be equally spaced on the sensorcarrier 20710 and can extend upwardly form a top surface of the sensorcarrier 20710. Each sharp carrier lock arm 20710K can include a sharpcarrier retention feature 20710L and a rib 20710M. Rib 20710M can engagean inner surface of the sheath 20704, which can urge the sharp carrierlock arm 20710K inwardly and cause sharp carrier retention feature20710L to retain sharp carrier 201102, as described in greater detailbelow. The carrier retention feature 20710L can have a triangle shapewhen viewed in side view and a “U” shape when viewed in top view.

In accordance with the disclosed subject matter, the sensor carrier20710 can include a plurality of lock ledges 20710N configured to engagelock arm interface 20704M of the sheath 20704 as described herein above.For example, the sensor carrier 20710 can include two lock ledges20710N. Sensor carrier 20710 can include recesses 20710O disposedproximate each lock ledge 20710N and configured to receive the lock arminterface 20704M during firing, to prevent the lock arm 20704J fromengaging with housing 20702 during firing. Sensor carrier 20710 caninclude a hole 20710P extending through a middle of the base 20710A. Thehole 20710P can guide and limit movement of sharp hub 205014 duringinsertion. Additionally, or alternatively, sensor carrier 20710 caninclude spring locator 20710Q.

A bottom surface of the sensor carrier 20710 can include stiffening ribs20710R and sensor locator ribs 20710S, which can limit planar motion ofthe sensor control device 20102 relative the sensor carrier 20710. Thebottom surface of the sensor carrier 20710 can include a sensor supportsurface 20710T configure to support the sensor control device 20102.

Exemplary Sharp Carriers

FIGS. 10A and 10B are a proximal perspective view and a sidecross-sectional view, respectively, depicting an example embodiment ofsharp carrier 2102. Sharp carrier 2102 can grasp and retain sharp module2500 within applicator 150. It can also automatically retract as aresult of one or more springs changing from a preloaded, compressedstate to an expanded state during an insertion process, as describedwith respect to FIGS. 40A-40F. Near a distal end of sharp carrier 2102can be anti-rotation slots 1608 which prevent sharp carrier 2102 fromrotating when located within a central area of sharp carrier lock arms1524 (as shown in FIG. 9A). Anti-rotation slots 1608 can be locatedbetween sections of sharp carrier base chamfer 1610, which can ensurefull retraction of sharp carrier 2102 through sheath 704 upon retractionof sharp carrier 2102 at the end of the deployment procedure.

As shown in FIG. 10B, sharp retention arms 1618 can be located in aninterior of sharp carrier 2102 about a central axis and can include asharp retention clip 1620 at a distal end of each arm 1618. Sharpretention clip 1620 can have a proximal surface which can be nearlyperpendicular to the central axis and can abut a distally facing surfaceof sharp hub 2516 (FIG. 17A).

Referring to FIGS. 10C and 10D, for purpose of illustration and notlimitation, an exemplary sharp carrier 201102 is provided. Sharp carrier201102 can include one or more features described herein with regard tosharp carriers, wherein similar features can operate as describe herein.For example, sharp carrier 201102 can include a series of features forengaging with the three sharp carrier lock arms 20710K of the sensorcarrier 20710. The features can include a pre-partial-retractionretention face 201102A and a post-partial-retraction retention face201102B. The pre-partial retraction retention face 201102A can engagethe sharp carrier retention feature 20710L prior to partial retraction,for example, during shipping and storage. Post-partial-retractionretention face 201102B can engage the sharp carrier retention feature20710L after partial retraction. For example, as the sheath 20704initially move proximally relative to the sensor carrier 20710, the rib20710M of the retention arm 20710L can engage slot 20704Q of sheath20704, which can allow the retention arm 20710L to move radially outwardand allow sharp carrier retention feature 20710L to clear thepre-partial retraction retention face 201102A and engage thepost-partial retraction retention face 201102B. A height between the endof the pre-partial-retraction face 201102A and the start of thepost-partial-retraction face 201102B can be the distance of the partialretraction. A running face 201102C can be disposed below thepost-partial-retraction retention face 201102B and can slide against theretention arm 20710L as the sharp carrier 201102 is retracted. Alignmentwalls 201102D can help to keep the sharp carrier 201102 aligned with thesensor carrier 20704 during partial retraction. Sharp carrier 201102 caninclude a chamfer 201102F, which can include anti-rotation slots 201102Eto engage the retention arms 20710L on the sensor carrier 20710.

Internally, sharp carrier 201102 can include sharp retention arms201102G including lead-in face 201102I and sharp hub contact face201102H. The retention arms 201102G can receive and hold sharp hub205014. Spring stop 201102J can engage retraction spring 205612.

Exemplary Sensor Modules

FIGS. 11A and 11B are a top perspective view and a bottom perspectiveview, respectively, depicting an example embodiment of sensor module504. Module 504 can hold a connector 2300 (FIGS. 12A and 12B) and asensor 104 (FIG. 13). Module 504 is capable of being securely coupledwith electronics housing 706. One or more deflectable arms or modulesnaps 2202 can snap into the corresponding features 2010 of housing 706.A sharp slot 2208 can provide a location for sharp tip 2502 to passthrough and sharp shaft 2504 to temporarily reside. A sensor ledge 2212can define a sensor position in a horizontal plane, prevent a sensorfrom lifting connector 2300 off of posts and maintain sensor 104parallel to a plane of connector seals. It can also define sensor bendgeometry and minimum bend radius. It can limit sensor travel in avertical direction and prevent a tower from protruding above anelectronics housing surface and define a sensor tail length below apatch surface. A sensor wall 2216 can constrain a sensor and define asensor bend geometry and minimum bend radius.

FIGS. 12A and 12B are perspective views depicting an example embodimentof connector 2300 in an open state and a closed state, respectively.Connector 2300 can be made of silicone rubber that encapsulatescompliant carbon impregnated polymer modules that serve as electricalconductive contacts 2302 between sensor 104 and electrical circuitrycontacts for the electronics within housing 706. The connector can alsoserve as a moisture barrier for sensor 104 when assembled in acompressed state after transfer from a container to an applicator andafter application to a user's skin. A plurality of seal surfaces 2304can provide a watertight seal for electrical contacts and sensorcontacts. One or more hinges 2208 can connect two distal and proximalportions of connector 2300.

FIG. 13 is a perspective view depicting an example embodiment of sensor104. A neck 2406 can be a zone which allows folding of the sensor, forexample ninety degrees. A membrane on tail 2408 can cover an activeanalyte sensing element of the sensor 104. Tail 2408 can be the portionof sensor 104 that resides under a user's skin after insertion. A flag2404 can contain contacts and a sealing surface. A biasing tower 2412can be a tab that biases the tail 2408 into sharp slot 2208. A biasfulcrum 2414 can be an offshoot of biasing tower 2412 that contacts aninner surface of a needle to bias a tail into a slot. A bias adjuster2416 can reduce a localized bending of a tail connection and preventsensor trace damage. Contacts 2418 can electrically couple the activeportion of the sensor to connector 2300. A service loop 2420 cantranslate an electrical path from a vertical direction ninety degreesand engage with sensor ledge 2212 (FIG. 11B).

FIGS. 14A and 14B are bottom and top perspective views, respectively,depicting an example embodiment of a sensor module assembly comprisingsensor module 504, connector 2300, and sensor 104. According to oneaspect of the aforementioned embodiments, during or after insertion,sensor 104 can be subject to axial forces pushing up in a proximaldirection against sensor 104 and into the sensor module 504, as shown byforce, F1, of FIG. 14A. According to some embodiments, this can resultin an adverse force, F2, being applied to neck 2406 of sensor 104 and,consequently, result in adverse forces, F3, being translated to serviceloop 2420 of sensor 104. In some embodiments, for example, axial forces,F1, can occur as a result of a sensor insertion mechanism in which thesensor is designed to push itself through the tissue, a sharp retractionmechanism during insertion, or due to a physiological reaction createdby tissue surrounding sensor 104 (e.g., after insertion).

FIGS. 15A and 15B are close-up partial views of an example embodiment ofa sensor module assembly having certain axial stiffening features. In ageneral sense, the embodiments described herein are directed tomitigating the effects of axial forces on the sensor as a result ofinsertion and/or retraction mechanisms, or from a physiological reactionto the sensor in the body. As can be seen in FIGS. 15A and 15B,according to one aspect of the embodiments, sensor 3104 comprises aproximal portion having a hook feature 3106 configured to engage a catchfeature 3506 of the sensor module 3504. In some embodiments, sensormodule 3504 can also include a clearance area 3508 to allow a distalportion of sensor 3104 to swing backwards during assembly to allow forthe assembly of the hook feature 3106 of sensor 3104 over and into thecatch feature 3506 of sensor module 3504.

According to another aspect of the embodiments, the hook and catchfeatures 3106, 3506 operate in the following manner. Sensor 3104includes a proximal sensor portion, coupled to sensor module 3504, asdescribed above, and a distal sensor portion that is positioned beneatha skin surface in contact with a bodily fluid. As seen in FIGS. 15A and15B, the proximal sensor portion includes a hook feature 3106 adjacentto the catch feature 3506 of sensor module 3504. During or after sensorinsertion, one or more forces are exerted in a proximal direction alonga longitudinal axis of sensor 3104. In response to the one or moreforces, hook feature 3106 engages catch feature 3506 to preventdisplacement of sensor 3104 in a proximal direction along thelongitudinal axis.

According to another aspect of the embodiments, sensor 3104 can beassembled with sensor module 3504 in the following manner. Sensor 3104is loaded into sensor module 3504 by displacing the proximal sensorportion in a lateral direction to bring the hook feature 3106 inproximity to the catch feature 3506 of sensor module 3504. Morespecifically, displacing the proximal sensor portion in a lateraldirection causes the proximal sensor portion to move into clearance area3508 of sensor module 3504.

Although FIGS. 15A and 15B depict hook feature 3106 as a part of sensor3104, and catch feature 3506 as a part of sensor module 3504, those ofskill in the art will appreciate that hook feature 3106 can instead be apart of sensor module 3504, and, likewise, catch feature 3506 caninstead be a part of sensor 3106. Similarly, those of skill in the artwill also recognize that other mechanisms (e.g., detent, latch,fastener, screw, etc.) implemented on sensor 3104 and sensor module 3504to prevent axial displacement of sensor 3104 are possible and within thescope of the present disclosure.

FIG. 15C is a side view of an example sensor 11900, according to one ormore embodiments of the disclosure. The sensor 11900 may be similar insome respects to any of the sensors described herein and, therefore, maybe used in an analyte monitoring system to detect specific analyteconcentrations. As illustrated, the sensor 11900 includes a tail 11902,a flag 11904, and a neck 11906 that interconnects the tail 11902 and theflag 11904. The tail 11902 includes an enzyme or other chemistry orbiologic and, in some embodiments, a membrane may cover the chemistry.In use, the tail 11902 is transcutaneously received beneath a user'sskin, and the chemistry included thereon helps facilitate analytemonitoring in the presence of bodily fluids.

The tail 11902 may be received within a hollow or recessed portion of asharp (not shown) to at least partially circumscribe the tail 11902 ofthe sensor 11900. As illustrated, the tail 11902 may extend at an angleQ offset from horizontal. In some embodiments, the angle Q may be about85°. Accordingly, in contrast to other sensor tails, the tail 11902 maynot extend perpendicularly from the flag 11904, but instead at an angleoffset from perpendicular. This may prove advantageous in helpingmaintain the tail 11902 within the recessed portion of the sharp.

The tail 11902 includes a first or bottom end 11908 a and a second ortop end 11908 b opposite the bottom end 11908 a. A tower 11910 may beprovided at or near the top end 11908 b and may extend vertically upwardfrom the location where the neck 11906 interconnects the tail 11902 tothe flag 11904. During operation, if the sharp moves laterally, thetower 11910 will help pivot the tail 11902 toward the sharp andotherwise stay within the recessed portion of the sharp. Moreover, insome embodiments, the tower 11910 may provide or otherwise define aprotrusion 11912 that extends laterally therefrom. When the sensor 11900is mated with the sharp and the tail 11902 extends within the recessedportion of the sharp, the protrusion 11912 may engage the inner surfaceof the recessed portion. In operation, the protrusion 11912 may helpkeep the tail 11902 within the recessed portion.

The flag 11904 may comprise a generally planar surface having one ormore sensor contacts 11914 arranged thereon. The sensor contact(s) 11914may be configured to align with a corresponding number of compliantcarbon impregnated polymer modules encapsulated within a connector.

In some embodiments, as illustrated, the neck 11906 may provide orotherwise define a dip or bend 11916 extending between the flag 11904and the tail 11902. The bend 11916 may prove advantageous in addingflexibility to the sensor 11900 and helping prevent bending of the neck11906.

In some embodiments, a notch 11918 (shown in dashed lines) mayoptionally be defined in the flag near the neck 11906. The notch 11918may add flexibility and tolerance to the sensor 11900 as the sensor11900 is mounted to the mount. More specifically, the notch 11918 mayhelp take up interference forces that may occur as the sensor 11900 ismounted within the mount.

In some embodiments, as illustrated in FIGS. 15D-15G, the neck cancomprise or otherwise define a non-linear configuration such as a dip orbend 11920 a-11920 d with a plurality of turns, e.g., 11921 a, 11921 b,extending between the flag 11904 and the tail 11902. The bend 11920a-11920 d can be advantageous in reducing in-place stiffness of thesensor 11900 by adding flexibility to the sensor 11900 in both avertically-oriented and horizontally-oriented direction. The addedflexibility can provide a multi-directional spring-like structure in thesensor 11900 that helps to limit deformation of the neck 11906 whileensuring that the tail 11902 and the flag 11904 can remain in theirexpected or fixed positions. The spring-like structure also increasescompliance of the sensor 11900 while reducing stress on the overallstructure.

Generally, the sensor can be understood as including a tail, a flag, anda neck aligned along a planar surface having a vertical axis and ahorizontal axis. The spring-like structure can be created by variousorientations of turns in the bend of the neck of a sensor. Between thetail and the flag, the neck can include at least two turns in relationto the vertical axis providing a spring-like structure. The at least twoturns can provide, in relation to an axis of the planar surface sharedby the tail, the flag, and the neck, overlapping layers of the structureof the neck, where the neck itself remains unbroken. These overlappingturns make up the spring-like structure. In some embodiments, theoverlapping layers of the neck are vertically-oriented. In someembodiments, the overlapping layers of the neck arehorizontally-oriented.

FIG. 15D illustrates one embodiment of a sensor 11900 including a neckbetween the flag 11904 and tail 11902 with a bend 11920 a includingturns 11921 a and 11921 b. In the illustrated embodiment, at least oneturn 11921 a abuts the top end of the tail or possibly the tower 11910of the sensor 11900. This orientation can be advantageous in that itreduces the overall footprint of the sensor, even considering theadditional material used to generate the bend 11920 a. The arrangementcan provide multiple overlapping, vertically-aligned horizontal layersbetween the turns.

FIG. 15E illustrates another embodiment of a sensor 11900 including aneck between the flag 11904 and tail 11902 with a bend 11920 b thatgenerally forms a swirl pattern including at least turn turns 11923 a,11923 b, and 11923 c. In this embodiment, the turns again abut the topend of the tail or the tower 11910 of the sensor 11900. In addition tomaintaining the overall footprint of the sensor, this orientation mayprovide for additional balancing of the horizontally-oriented andvertically-oriented stresses. The overlapping layers in this arrangementof turns are substantially balanced in along both the horizontal andvertical axes.

FIG. 15F illustrates another embodiment of a sensor 11900 including aneck between the flag 11904 and tail 11902 with a bend 11920 c includingturns 11925 a, 11925 b, and 11925 c. In the illustrated embodiment, theturn 11925 c connects a region of the tail 11902 near the top end of thetail or the tower 11910 of the sensor to the rest of the bend 11920 c.In addition to reducing the overall footprint of the sensor, thisorientation can be considered to provide additional flexibility in thehorizontally-oriented axis. The arrangement can provide multipleoverlapping, horizontally-aligned vertical layers between the turns.

FIG. 15G illustrates another embodiment of a sensor 11900 including aneck between the flag 11904 and tail 11902 with a bend 11920 d includingturn 11927 a, 11927 b, and 11927 c. In the illustrated embodiment, thebend 11920 d occurs primarily in the tail 11902 of the sensor,connecting the tail 11902 and the tower 11910, while the stretch of thesensor between the tower 11910 and the flag 11904 is generallyuninterrupted. The turn 11927 a generally connects the tower 11910 tothe rest of the bend 11920 d, while the turn 11927 c connects the tail11902 to the rest of the bend 11920 d. This orientation can beconsidered to provide additional flexibility in the vertically-orientedaxis. The arrangement can provide multiple overlapping,horizontally-aligned vertical layers between the turns.

The turns of the neck can be created by folding the neck of the sensorfrom a larger neck structure, laser cutting the sensor from a sheet ofthe material comprising the sensor, printing the sensor having theconfiguration with turns, stamping the sensor from a sheet of materialof which the sensor is composed, or other suitable manufacturingprocesses for providing precision bends in the neck.

FIGS. 16A and 16B are isometric and partially exploded isometric viewsof an example connector assembly 12000, according to one or moreembodiments. As illustrated, the connector assembly 12000 may include aconnector 12002, and FIG. 17C is an isometric bottom view of theconnector 12002. The connector 12002 may comprise an injection moldedpart used to help secure one or more compliant carbon impregnatedpolymer modules 12004 (four shown in FIG. 16B) to a mount 12006. Morespecifically, the connector 12002 may help secure the modules 12004 inplace adjacent the sensor 11900 and in contact with the sensor contacts11914 (FIG. 15C) provided on the flag 11904 (FIG. 15C). The modules12004 may be made of a conductive material to provide conductivecommunication between the sensor 11900 and corresponding circuitrycontacts (not shown) provided within the mount 12006.

As best seen in FIG. 16C, the connector 12002 may define pockets 12008sized to receive the modules 12004. Moreover, in some embodiments, theconnector 12002 may further define one or more depressions 12010configured to mate with one or more corresponding flanges 12012 (FIG.16B) on the mount 12006. Mating the depressions 12010 with the flanges12012 may secure the connector 12002 to the mount 12006 via aninterference fit or the like. In other embodiments, the connector 12002may be secured to the mount 12006 using an adhesive or via sonicwelding.

FIGS. 16D and 16E are isometric and partially exploded isometric viewsof another example connector assembly 12100, according to one or moreembodiments. As illustrated, the connector assembly 12100 may include aconnector 12102, and FIG. 16F is an isometric bottom view of theconnector 12102. The connector 12102 may comprise an injection moldedpart used to help keep one or more compliant metal contacts 12104 (fourshown in FIG. 16E) secured against the sensor 11900 on a mount 12106.More specifically, the connector 12102 may help secure the contacts12104 in place adjacent the sensor 11900 and in contact with the sensorcontacts 11914 (FIG. 15C) provided on the flag 11904. The contacts 12104may be made of a stamped conductive material that provides conductivecommunication between the sensor 11900 and corresponding circuitrycontacts (not shown) provided within the mount 12106. In someembodiments, for example, the contacts 12104 may be soldered to a PCB(not shown) arranged within the mount 12106.

As best seen in FIG. 16F, the connector 12102 may define pockets 12108sized to receive the contacts 12104. Moreover, in some embodiments, theconnector 12102 may further define one or more depressions 12110configured to mate with one or more corresponding flanges 12112 (FIG.120B) on the mount 12006. Mating the depressions 12110 with the flanges12112 may help secure the connector 12102 to the mount 12106 via aninterference fit or the like. In other embodiments, the connector 12102may be secured to the mount 12106 using an adhesive or via sonicwelding.

Exemplary Sharp Modules

FIG. 17A is a perspective view depicting an example embodiment of sharpmodule 2500 prior to assembly within sensor module 504 (FIG. 6B). Sharp2502 can include a distal tip 2506 which can penetrate the skin whilecarrying sensor tail in a hollow or recess of sharp shaft 2504 to putthe active surface of the sensor tail into contact with bodily fluid. Ahub push cylinder 2508 can provide a surface for a sharp carrier to pushduring insertion. A hub small cylinder 2512 can provide a space for theextension of sharp hub contact faces 1622 (FIG. 10B). A hub snap pawllocating cylinder 2514 can provide a distal-facing surface of hub snappawl 2516 for sharp hub contact faces 1622 to abut. A hub snap pawl 2516can include a conical surface that opens clip 1620 during installationof sharp module 2500.

FIGS. 17B to 17H show example embodiments of sharp modules, in variousstages of assembly, for use in the insertion of dermal analyte sensors.According to one aspect of the embodiments, angling the sensor and/orinsertion sharp relative to a reference point can enable co-localizationof the tip of the insertion needle and the tip of the sensor, andfurthermore, can create a single contact point at the surface of theskin. As such, the sharp can create a leading edge at the surface of theskin to form an insertion path into the dermal layer for the sensor, asthe sensor is inserted into a subject. In some embodiments, for example,the sharp and/or dermal sensor may be angled relative to a referencepoint (e.g., each other, surface of the skin, or the base of theapplicator) for insertion, where the angle of the sharp differs from theangle of the sensor. For example, the reference point may be the skinsurface to be breached for dermal insertion, or may be a reference orcomponent of the sensor applicator set. In some embodiments, the sharpmay be disposed at an angle relative to the sensor. For example, whendesigned so that that the sharp is angled relative to the sensor, theneedle creates a leading edge for the sensor during operation of theapplicator set. Furthermore, the needle design itself, and thepositioning of the needle with respect to the sensor can be implementedin any desired configuration, including all of those configurationsdisclosed in U.S. Patent Publication No. 2014/0171771, which isincorporated by reference herein in its entirety for all purposes.

Furthermore, although many of the example embodiments described withrespect to FIGS. 17B to 17J make reference to dermal analyte sensors anddermal insertion, it will be understood by those of skill in the artthat any of the embodiments can be dimensioned and configured for usewith analyte sensors that can be positioned beyond the dermal space,such as into (or even fully through) subcutaneous tissue (e.g., 3 mm to10 mm beneath the surface of the skin depending on the location of theskin on the body).

FIG. 17B is a perspective view depicting an example embodiment of asharp module 2550 that can be used for the insertion of a dermal sensor.Sharp module 2550 is shown here prior to assembly with sensor module 504(FIG. 6B), and can include components similar to those of the embodimentdescribed with respect to FIG. 17A, including sharp 2552, sharp shaft2554, sharp distal tip 2556, hub push cylinder 2558, hub small cylinder2562, hub snap pawl 2566 and hub snap pawl locating cylinder 2564. Sharp2552 can be positioned within sharp module 2550 at an off-centerlocation relative to a longitudinal axis 2545 that extends throughcenter of hub snap pawl 2566, hub small cylinder 2562 and hub pushcylinder 2558. In addition, sharp module 2550 can include a sharp spacer2568 that is parallel to and adjacent with a portion of sharp 2552.Sharp spacer 2568 can be positioned in between sensor 104 (not shown)and sharp 2552 along a proximal portion of sharp 2552, and can ensurethat sensor 104 and sharp 2552 remain spaced apart at a proximal portionof sharp 2552. Sharp 2552 can be positioned in an off-center locationduring a molding process with hub components 2558, 2562, 2566, each ofwhich may consist of a rigid plastic material.

FIGS. 17C and 17D are two side views depicting sharp module 2550 priorto assembly with sensor module 504 (FIG. 6B), and include sharp 2552,spacer 2568, hub push cylinder 2558, hub small cylinder 2562 and hubsnap pawl 2566. In some embodiments, the relative distances between thesharp 2552 and hub components can be positioned as follows. For example,distance, S₁, between the sharp 2552 and the radial center of hub canrange from 0.50 mm to 1 mm (e.g., 0.89 mm). Height, S₂, of sharp spacer2568 can range from 3 to 5 mm (e.g., 3.26 mm). Height, S₃, of hub canrange from 5 to 10 mm (e.g., 6.77 mm). Length, S₄, of sharp 2552 canrange from 1.5 mm to 25 mm (e.g., 8.55 mm), and may depend on thelocation of the insertion site on the subject.

FIG. 17E depicts a side cross-sectional side view of sharp module 2550,including sharp 2552, sharp spacer 2568 and hub components (hub snappawl 2566, hub small cylinder 2562, and hub push cylinder 2558), asassembled with sensor module 504. As can be seen in FIG. 17E, sharp 2552is positioned within sharp slot 2208 of sensor module 504 that includesa curved interior surface 2250, located at a distal end. Curved interiorsurface 2250 of sensor module 504 can be in contact with a portion ofsharp 2552 and cause a deflection such that sharp distal tip 2556 isoriented toward central longitudinal axis 2545. As best seen in FIG.17H, sharp 2552 can be positioned such that the distal portion andcentral longitudinal axis 2545 form an acute angle, Se, that can rangebetween 5° and 20°. In some embodiments, for example, Se, can range from5° to 17°, or 7° to 15°, or 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13°

Referring still to FIG. 17E, near a distal end of sensor module 504 isprotrusion 2251, which can enhance the perfusion of bodily fluid, suchas dermal fluid. Although shown as a curved surface in FIG. 17E,protrusion 2251 can be shaped in any desired fashion. In addition, insome embodiments, multiple protrusions can be present. U.S. PatentPublication No. 2014/0275907, which is incorporated by reference hereinin its entirety for all purposes, describes sensor devices havingdifferent protrusion configurations, each of which can be implementedwith the embodiments described herein. Many of the embodiments describedherein show the needle exiting from the protrusion, and in otherembodiments, the needle can exit from the base of the sensor deviceadjacent the protrusion, and from that position extend over the tip ofsensor 104.

Referring still to FIGS. 17E and 17F, sensor 104 can be a dermal sensorand can include sensor tail 2408, located at a distal end of sensor 104,and which can be positioned in a substantially parallel orientation tocentral longitudinal axis 2545. Distal end of sensor tail 2408 can beproximal to distal sharp tip 2556, either in a spaced relation with, atrest in, or at rest against a portion of sharp shaft 2554. As furtherdepicted in FIG. 17E, sharp spacer 2568 provides a spaced relationbetween a proximal portion of sharp 2552 and sensor 104, such that theproximal portion of sharp 2552 and sensor 104 are not in contact. Sensormodule 504 can further include sensor connector 2300 for housing aproximal portion of sensor 104 that is relatively perpendicular to adistal end of sensor 104.

FIG. 17F is a top-down cross-sectional view of sensor module 504. Sensormodule 504 can include one or more sensor module snaps 2202 for couplingwith a housing (not shown) of sensor control device 102. Sensor module504 can also include sensor connector 2300, which can have sensorcontacts 2302 for coupling with a proximal portion of sensor 104. Sensorconnector 2300 can be made of silicone rubber that encapsulatescompliant carbon impregnated polymer modules that serve as electricalconductive contacts 2302 between sensor 104 and electrical circuitrycontacts for the electronics within sensor control device 102. Theconnector can also serve as a moisture barrier for sensor 104 whenassembled in a compressed state after transfer from a container to anapplicator and after application to a user's skin. Although threecontacts 2302 are depicted, it should be understood that connector 2300can have fewer contacts (e.g., two) or more contacts (e.g., four, five,six, etc.), depending on the particular type or configuration of sensor104. Sensor connector 2300 can be further coupled with sensor module 504by two connector posts 2206 positioned through a like number ofapertures in connector 2300. Although two connector posts 2206 aredepicted, it should be understood that any number of connector posts2206 can be used to couple connector 2300 to sensor module 504.

FIGS. 17G and 17H are, respectively, a perspective view and a side viewof another example embodiment of sharp module 2600 that can be used forthe insertion of a dermal sensor. Sharp module 2600 is shown here priorto assembly with sensor module 504 (FIG. 6B), and can include componentssimilar to those of the embodiments described with respect to FIGS. 17Aand 17B, including sharp 2602, sharp shaft 2604, sharp distal tip 2606,hub push cylinder 2608, hub small cylinder 2612, hub snap pawl 2616 andhub snap pawl locating cylinder 2614. In some embodiments, sharp 2602can be a “pre-bent” needle that includes a proximal portion 2603 thatoriginates from a point external to sharp module 2600 and intersects, atan angle, a central point of the hub (e.g., through hub push cylinder2608). Sharp 2602 can also include a distal portion 2605 that extends ina distal direction, at an angle, from a point near a distal portion ofhub toward the insertion point of the user's skin. As shown in FIG. 17H,sharp 2602 can include an angled portion 2607 located external to hubpush cylinder 2608, which can have a substantially 90° angle betweenproximal portion 2603 and distal portion 2605 of sharp 2602. Sharpmodule 2600 can also include a bend fin guide 2620 for maintaining“pre-bent” sharp 2602 in position during assembly and/or use, and canprevent lateral or rotational movement of sharp 2602 relative to hubcomponents. Proximal portion 2603 of sharp 2602 can be “trimmed” fromthe hub after molding process is completed, and prior to assembly ofsharp module 2600 with sensor module 504.

FIGS. 171 and 17J show, respectively, a side cross-sectional view and aside view of sharp module 2600 (including hub snap pawl 2616, hub smallcylinder 2612, and hub push cylinder 2608), as assembled with sensormodule 504. As can be seen in FIG. 17I, sensor module 504 includes sharpslot 2208, through which sharp 2602 can extend in an angled and distaldirection. As described earlier, a proximal portion of sharp 2602 passesthrough bend fin guide 2620, which is coupled with a distal portion ofsensor module 504. Sensor module 504 can also include sensor 104, whichcan be a dermal sensor. As seen in FIG. 17I, sharp 2602 and sensor tail2408 can form an acute angle, S_(Θ), at a point where their respectivelongitudinal axes converge. Angle S_(Θ) can range between 5° and 20°. Insome embodiments, for example, So, can range from 5° to 17°, or 7° to15°, or 9° to 13°, e.g., 9°, 10°, 11°, 12°, or 13° In some embodiments,distal sharp tip 2606 is located at a distance, S₆, that is proximal toan end of sensor tail 2408. Distance, S₆, can range between 0.02 mm to0.10 mm, e.g., 0.05 mm, 0.06 mm or 0.07 mm.

Referring still to FIGS. 171 and 17J, sensor module 504 can also includesensor connector 2300 for housing a proximal portion of sensor 104 thatis relatively perpendicular to a distal end of sensor 104. Sensor module504 can further include one or more sensor module snaps 2202 forcoupling with a housing (not shown) of sensor control device 102. Sensorconnector 2300 can include the same structures described with respect toFIG. 17F.

In the above embodiments, the sharp can be made of stainless steel or alike flexible material (e.g., material used to manufacture acupunctureneedles), and dimensioned such that the applicator provides forinsertion of at least a portion of the dermal sensor into the dermallayer, but not through the dermal layer of the skin. According tocertain embodiments, the sharp has a cross sectional diameter (width) offrom 0.1 mm to 0.5 mm. For example, the sharp may have a diameter offrom 0.1 mm to 0.3 mm, such as from 0.15 mm to 0.25 mm, e.g., 0.16 mm to0.22 mm in diameter. A given sharp may have a constant, i.e., uniform,width along its entire length, or may have a varying, i.e., changing,width along at least a portion of its length, such as the tip portionused to pierce the surface of the skin. For example, with respect to theembodiment shown in FIG. 17I, width of sharp 2602 can narrow along adistal portion between bend fin guide 1620 and distal sharp tip 2606.

A sharp can also have a length to insert a dermal sensor just into thedermal layer, and no more. Insertion depth may be controlled by thelength of the sharp, the configuration of the base and/or otherapplicator components that limit insertion depth. A sharp may have alength between 1.5 mm and 25 mm. For example, the sharp may have alength of from 1 mm to 3 mm, from 3 mm to 5 mm, from 5 mm to 7 mm, from7 mm to 9 mm, from 9 mm to 11 mm, from 11 mm to 13 mm, from 13 mm to 15mm, from 15 mm to 17 mm, from 17 mm to 19 mm, from 19 mm to 21 mm, from21 mm to 23 mm, from 23 mm to 25 mm, or a length greater than 25 mm. Itwill be appreciated that while a sharp may have a length up to 25 mm, incertain embodiments the full length of the sharp is not inserted intothe subject because it would extend beyond the dermal space.Non-inserted sharp length may provide for handling and manipulation ofthe sharp in an applicator set. Therefore, while a sharp may have alength up to 25 mm, the insertion depth of the sharp in the skin on asubject in those certain embodiments will be limited to the dermallayer, e.g., about 1.5 mm to 4 mm, depending on the skin location, asdescribed in greater detail below. However, in all of the embodimentsdisclosed herein, the sharp can be configured to extend beyond thedermal space, such as into (or even fully through) subcutaneous tissue(e.g., 3 mm to 10 mm beneath the surface of the skin depending on thelocation of the skin on the body). Additionally, in some exampleembodiments, the sharps described herein can include hollow or partiallyhollow insertion needles, having an internal space or lumen. In otherembodiments, however, the sharps described herein can include solidinsertion needles, which do not have an internal space and/or lumen.Furthermore, a sharp of the subject applicator sets can also be bladedor non-bladed.

Likewise, in the above embodiments, a dermal sensor is sized so that atleast a portion of the sensor is positioned in the dermal layer and nomore, and a portion extends outside the skin in the transcutaneouslypositioned embodiments. That is, a dermal sensor is dimensioned suchthat when the dermal sensor is entirely or substantially entirelyinserted into the dermal layer, the distal-most portion of the sensor(the insertion portion or insertion length) is positioned within thedermis of the subject and no portion of the sensor is inserted beyond adermal layer of the subject when the sensor is operably dermallypositioned.

The dimensions (e.g., the length) of the sensor may be selectedaccording to the body site of the subject in which the sensor is to beinserted, as the depth and thickness of the epidermis and dermis exhibita degree of variability depending on skin location. For example, theepidermis is only about 0.05 mm thick on the eyelids, but about 1.5 mmthick on the palms and the soles of the feet. The dermis is the thickestof the three layers of skin and ranges from about 1.5 mm to 4 mm thick,depending on the skin location. For implantation of the distal end ofthe sensor into, but not through, the dermal layer of the subject, thelength of the inserted portion of the dermal sensor should be greaterthan the thickness of the epidermis, but should not exceed the combinedthickness of the epidermis and dermis. Methods may include determiningan insertion site on a body of a user and determining the depth of thedermal layer at the site, and selecting the appropriately-sizedapplicator set for the site.

In certain aspects, the sensor is an elongate sensor having a longestdimension (or “length”) of from 0.25 mm to 4 mm. The length of thesensor that is inserted, in the embodiments in which only a portion of asensor is dermally inserted, ranges from 0.5 mm to 3 mm, such as from 1mm to 2 mm, e.g., 1.5 mm. The dimensions of the sensor may also beexpressed in terms of its aspect ratio. In certain embodiments, a dermalsensor has an aspect ratio of length to width (diameter) of about 30:1to about 6:1. For example, the aspect ratio may be from about 25:1 toabout 10:1, including 20:1 and 15:1. The inserted portion of a dermalsensor has sensing chemistry.

However, all of the embodiments disclosed herein can be configured suchthat at least a portion of the sensor is positioned beyond the dermallayer, such as into (or through) the subcutaneous tissue (or fat). Forexample, the sensor can be dimensioned such that when the sensor isentirely or substantially entirely inserted into the body, thedistal-most portion of the sensor (the insertion portion or insertionlength) is positioned within the subcutaneous tissue (beyond the dermisof the subject) and no portion of the sensor is inserted beyond thesubcutaneous tissue of the subject when the sensor is operablypositioned. As mentioned, the subcutaneous tissue is typically presentin the region that is 3 mm to 10 mm beneath the outer skin surface,depending on the location of the skin on the body.

Exemplary Applicators and Sensor Control Devices for One PieceArchitectures

Referring briefly again to FIGS. 1 and 3A-3G, for the two-piecearchitecture system, the sensor tray 202 and the sensor applicator 102are provided to the user as separate packages, thus requiring the userto open each package and finally assemble the system. In someapplications, the discrete, sealed packages allow the sensor tray 202and the sensor applicator 102 to be sterilized in separate sterilizationprocesses unique to the contents of each package and otherwiseincompatible with the contents of the other. More specifically, thesensor tray 202, which includes the plug assembly 207, including thesensor 110 and the sharp 220, may be sterilized using radiationsterilization, such as electron beam (or “e-beam”) irradiation.Radiation sterilization, however, can damage the electrical componentsarranged within the electronics housing of the sensor control device102. Consequently, if the sensor applicator 102, which contains theelectronics housing of the sensor control device 102, needs to besterilized, it may be sterilized via another method, such as gaseouschemical sterilization using, for example, ethylene oxide. Gaseouschemical sterilization, however, can damage the enzymes or otherchemistry and biologies included on the sensor 110. Because of thissterilization incompatibility, the sensor tray 202 and the sensorapplicator 102 are commonly sterilized in separate sterilizationprocesses and subsequently packaged separately, which requires the userto finally assemble the components for use.

According to embodiments of the present disclosure, the sensor controldevice 102 may be modified to provide a one-piece architecture that maybe subjected to sterilization techniques specifically designed for aone-piece architecture sensor control device. A one-piece architectureallows the sensor applicator 150 and the sensor control device 102 to beshipped to the user in a single, sealed package that does not requireany final user assembly steps. Rather, the user need only open onepackage and subsequently deliver the sensor control device 102 to thetarget monitoring location. The one-piece system architecture describedherein may prove advantageous in eliminating component parts, variousfabrication process steps, and user assembly steps. As a result,packaging and waste are reduced, and the potential for user error orcontamination to the system is mitigated.

FIGS. 18A and 18B are isometric and side views, respectively, of anotherexample sensor control device 5002, according to one or more embodimentsof the present disclosure. The sensor control device 5002 may be similarin some respects to the sensor control device 102 of FIG. 1 andtherefore may be best understood with reference thereto. Moreover, thesensor control device 5002 may replace the sensor control device 102 ofFIG. 1 and, therefore, may be used in conjunction with the sensorapplicator 102 of FIG. 1, which may deliver the sensor control device5002 to a target monitoring location on a user's skin.

Unlike the sensor control device 102 of FIG. 1, however, the sensorcontrol device 5002 may comprise a one-piece system architecture notrequiring a user to open multiple packages and finally assemble thesensor control device 5002 prior to application. Rather, upon receipt bythe user, the sensor control device 5002 may already be fully assembledand properly positioned within the sensor applicator 150 (FIG. 1). Touse the sensor control device 5002, the user need only open one barrier(e.g., the applicator cap 708 of FIG. 3B) before promptly delivering thesensor control device 5002 to the target monitoring location for use.

As illustrated, the sensor control device 5002 includes an electronicshousing 5004 that is generally disc-shaped and may have a circularcross-section. In other embodiments, however, the electronics housing5004 may exhibit other cross-sectional shapes, such as ovoid orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 5004 may be configured to house or otherwise containvarious electrical components used to operate the sensor control device5002. In at least one embodiment, an adhesive patch (not shown) may bearranged at the bottom of the electronics housing 5004. The adhesivepatch may be similar to the adhesive patch 105 of FIG. 1, and may thushelp adhere the sensor control device 5002 to the user's skin for use.

As illustrated, the sensor control device 5002 includes an electronicshousing 5004 that includes a shell 5006 and a mount 5008 that is matablewith the shell 5006. The shell 5006 may be secured to the mount 5008 viaa variety of ways, such as a snap fit engagement, an interference fit,sonic welding, one or more mechanical fasteners (e.g., screws), agasket, an adhesive, or any combination thereof. In some cases, theshell 5006 may be secured to the mount 5008 such that a sealed interfaceis generated therebetween.

The sensor control device 5002 may further include a sensor 5010(partially visible) and a sharp 5012 (partially visible), used to helpdeliver the sensor 5010 transcutaneously under a user's skin duringapplication of the sensor control device 5002. As illustrated,corresponding portions of the sensor 5010 and the sharp 5012 extenddistally from the bottom of the electronics housing 5004 (e.g., themount 5008). The sharp 5012 may include a sharp hub 5014 configured tosecure and carry the sharp 5012. As best seen in FIG. 18B, the sharp hub5014 may include or otherwise define a mating member 5016. To couple thesharp 5012 to the sensor control device 5002, the sharp 5012 may beadvanced axially through the electronics housing 5004 until the sharphub 5014 engages an upper surface of the shell 5006 and the matingmember 5016 extends distally from the bottom of the mount 5008. As thesharp 5012 penetrates the electronics housing 5004, the exposed portionof the sensor 5010 may be received within a hollow or recessed (arcuate)portion of the sharp 5012. The remaining portion of the sensor 5010 isarranged within the interior of the electronics housing 5004.

The sensor control device 5002 may further include a sensor cap 5018,shown exploded or detached from the electronics housing 5004 in FIGS.18A-18B. The sensor cap 5016 may be removably coupled to the sensorcontrol device 5002 (e.g., the electronics housing 5004) at or near thebottom of the mount 5008. The sensor cap 5018 may help provide a sealedbarrier that surrounds and protects the exposed portions of the sensor5010 and the sharp 5012 from gaseous chemical sterilization. Asillustrated, the sensor cap 5018 may comprise a generally cylindricalbody having a first end 5020 a and a second end 5020 b opposite thefirst end 5020 a. The first end 5020 a may be open to provide accessinto an inner chamber 5022 defined within the body. In contrast, thesecond end 5020 b may be closed and may provide or otherwise define anengagement feature 5024. As described herein, the engagement feature5024 may help mate the sensor cap 5018 to the cap (e.g., the applicatorcap 708 of FIG. 3B) of a sensor applicator (e.g., the sensor applicator150 of FIGS. 1 and 3A-3G), and may help remove the sensor cap 5018 fromthe sensor control device 5002 upon removing the cap from the sensorapplicator.

The sensor cap 5018 may be removably coupled to the electronics housing5004 at or near the bottom of the mount 5008. More specifically, thesensor cap 5018 may be removably coupled to the mating member 5016,which extends distally from the bottom of the mount 5008. In at leastone embodiment, for example, the mating member 5016 may define a set ofexternal threads 5026 a (FIG. 18B) matable with a set of internalthreads 5026 b (FIG. 18A) defined by the sensor cap 5018. In someembodiments, the external and internal threads 5026 a, b may comprise aflat thread design (e.g., lack of helical curvature), which may proveadvantageous in molding the parts. Alternatively, the external andinternal threads 5026 a,b may comprise a helical threaded engagement.Accordingly, the sensor cap 5018 may be threadably coupled to the sensorcontrol device 5002 at the mating member 5016 of the sharp hub 5014. Inother embodiments, the sensor cap 5018 may be removably coupled to themating member 5016 via other types of engagements including, but notlimited to, an interference or friction fit, or a frangible member orsubstance that may be broken with minimal separation force (e.g., axialor rotational force).

In some embodiments, the sensor cap 5018 may comprise a monolithic(singular) structure extending between the first and second ends 5020 a,b. In other embodiments, however, the sensor cap 5018 may comprise twoor more component parts. In the illustrated embodiment, for example, thesensor cap 5018 may include a seal ring 5028 positioned at the first end5020 a and a desiccant cap 5030 arranged at the second end 5020 b. Theseal ring 5028 may be configured to help seal the inner chamber 5022, asdescribed in more detail below. In at least one embodiment, the sealring 5028 may comprise an elastomeric O-ring. The desiccant cap 5030 mayhouse or comprise a desiccant to help maintain preferred humidity levelswithin the inner chamber 5022. The desiccant cap 5030 may also define orotherwise provide the engagement feature 5024 of the sensor cap 5018.

FIGS. 19A and 19B are exploded isometric top and bottom views,respectively, of the sensor control device 5002, according to one ormore embodiments. The shell 5006 and the mount 5008 operate as opposingclamshell halves that enclose or otherwise substantially encapsulatevarious electronic components of the sensor control device 5002. Morespecifically, electronic components may include, but are not limited to,a printed circuit board (PCB), one or more resistors, transistors,capacitors, inductors, diodes, and switches. A data processing unit anda battery may be mounted to or otherwise interact with the PCB. The dataprocessing unit may comprise, for example, an application specificintegrated circuit (ASIC) configured to implement one or more functionsor routines associated with operation of the sensor control device 5002.More specifically, the data processing unit may be configured to performdata processing functions, where such functions may include, but are notlimited to, filtering and encoding of data signals, each of whichcorresponds to a sampled analyte level of the user. The data processingunit may also include or otherwise communicate with an antenna forcommunicating with the reader device 120 (FIG. 1). The battery mayprovide power to the sensor control device 5002 and, more particularly,to the electronic components of the PCB. While not shown, the sensorcontrol device 5002 may also include an adhesive patch that may beapplied to the bottom 5102 (FIG. 19B) of the mount 5008, and may helpadhere the sensor control device 5002 to the user's skin for use.

The sensor control device 5002 may provide or otherwise include a sealedsubassembly that includes, among other component parts, the shell 5006,the sensor 5010, the sharp 5012, and the sensor cap 5018. The sealedsubassembly of the sensor control device 5002 may help isolate thesensor 5010 and the sharp 5012 within the inner chamber 5022 (FIG. 19A)of the sensor cap 5018 during a gaseous chemical sterilization process,which might otherwise adversely affect the chemistry provided on thesensor 5010.

The sensor 5010 may include a tail 5104 that extends out an aperture5106 (FIG. 19B) defined in the mount 5008 to be transcutaneouslyreceived beneath a user's skin. The tail 5104 may have an enzyme orother chemistry included thereon to help facilitate analyte monitoring.The sharp 5012 may include a sharp tip 5108 extendable through anaperture 5110 (FIG. 19A) defined by the shell 5006, and the aperture5110 may be coaxially aligned with the aperture 5106 of the mount 5008.As the sharp tip 5108 penetrates the electronics housing 5004, the tail5104 of the sensor 5010 may be received within a hollow or recessedportion of the sharp tip 5108. The sharp tip 5108 may be configured topenetrate the skin while carrying the tail 5104 to put the activechemistry of the tail 5104 into contact with bodily fluids.

The sharp tip 5108 may be advanced through the electronics housing 5004until the sharp hub 5014 engages an upper surface of the shell 5006 andthe mating member 5016 extends out the aperture 5106 in the bottom 5102of the mount 5008. In some embodiments, a seal member (not shown), suchas an O-ring or seal ring, may interpose the sharp hub 5014 and theupper surface of the shell 5006 to help seal the interface between thetwo components. In some embodiments, the seal member may comprise aseparate component part, but may alternatively form an integral part ofthe shell 5006, such as being a co-molded or overmolded component part.

The sealed subassembly may further include a collar 5112 that ispositioned within the electronics housing 5004 and extends at leastpartially into the aperture 5106. The collar 5112 may be a generallyannular structure that defines or otherwise provides an annular ridge5114 on its top surface. In some embodiments, as illustrated, a groove5116 may be defined in the annular ridge 5114 and may be configured toaccommodate or otherwise receive a portion of the sensor 5010 extendinglaterally within the electronics housing 5004.

In assembling the sealed subassembly, a bottom 5118 of the collar 5112may be exposed at the aperture 5106 and may sealingly engage the firstend 5020 a of the sensor cap 5018 and, more particularly, the seal ring5028. In contrast, the annular ridge 5114 at the top of the collar 5112may sealingly engage an inner surface (not shown) of the shell 5006. Inat least one embodiment, a seal member (not shown) may interpose theannular ridge 5114 and the inner surface of the shell 5006 to form asealed interface. In such embodiments, the seal member may also extend(flow) into the groove 5116 defined in the annular ridge 5114 andthereby seal about the sensor 5010 extending laterally within theelectronics housing 5004. The seal member may comprise, for example, anadhesive, a gasket, or an ultrasonic weld, and may help isolate theenzymes and other chemistry included on the tail 5104.

FIG. 20 is a cross-sectional side view of an assembled sealedsubassembly 5200, according to one or more embodiments. The sealedsubassembly 5200 may form part of the sensor control device 5002 ofFIGS. 18A-18B and 19A-20B and may include portions of the shell 5006,the sensor 5010, the sharp 5012, the sensor cap 5018, and the collar5112. The sealed subassembly 5200 may be assembled in a variety of ways.In one assembly process, the sharp 5012 may be coupled to the sensorcontrol device 5002 by extending the sharp tip 5108 through the aperture5110 defined in the top of the shell 5006 and advancing the sharp 5012through the shell 5006 until the sharp hub 5014 engages the top of theshell 5006 and the mating member 5016 extends distally from the shell5006. In some embodiments, as mentioned above, a seal member 5202 (e.g.,an O-ring or seal ring) may interpose the sharp hub 5014 and the uppersurface of the shell 5006 to help seal the interface between the twocomponents.

The collar 5112 may then be received over (about) the mating member 5016and advanced toward an inner surface 5204 of the shell 5006 to enablethe annular ridge 5114 to engage the inner surface 5204. A seal member5206 may interpose the annular ridge 5114 and the inner surface 5204 andthereby form a sealed interface. The seal member 5206 may also extend(flow) into the groove 5116 (FIGS. 19A-20B) defined in the annular ridge5114 and thereby seal about the sensor 5010 extending laterally withinthe electronics housing 5004 (FIGS. 19A-20B). In other embodiments,however, the collar 5112 may first be sealed to the inner surface 5204of the shell 5006, following which the sharp 5012 and the sharp hub 5014may be extended through the aperture 5110, as described above.

The sensor cap 5018 may be removably coupled to the sensor controldevice 5002 by threadably mating the internal threads 5026 b of thesensor cap 5018 with the external threads 5026 a of the mating member5016. Tightening (rotating) the mated engagement between the sensor cap5018 and the mating member 5016 may urge the first end 5020 a of thesensor cap 5018 into sealed engagement with the bottom 5118 of thecollar 5112. Moreover, tightening the mated engagement between thesensor cap 5018 and the mating member 5016 may also enhance the sealedinterface between the sharp hub 5014 and the top of the shell 5006, andbetween the annular ridge 5114 and the inner surface 5204 of the shell5006.

The inner chamber 5022 may be sized and otherwise configured to receivethe tail 5104 and the sharp tip 5108. Moreover, the inner chamber 5022may be sealed to isolate the tail 5104 and the sharp tip 5108 fromsubstances that might adversely interact with the chemistry of the tail5104. In some embodiments, a desiccant 5208 (shown in dashed lines) maybe present within the inner chamber 5022 to maintain proper humiditylevels.

Once properly assembled, the sealed subassembly 5200 may be subjected toany of the radiation sterilization processes mentioned herein toproperly sterilize the sensor 5010 and the sharp 5012. Thissterilization step may be undertaken apart from the remaining portionsof the sensor control device (FIGS. 18A-18B and 19A-20B) to preventdamage to sensitive electrical components. The sealed subassembly 5200may be subjected to radiation sterilization prior to or after couplingthe sensor cap 5018 to the sharp hub 5014. When sterilized aftercoupling the sensor cap 5018 to the sharp hub 5014, the sensor cap 5018may be made of a material that permits the propagation of radiationtherethrough. In some embodiments, the sensor cap 5018 may betransparent or translucent, but can otherwise be opaque, withoutdeparting from the scope of the disclosure.

FIGS. 21A-21C are progressive cross-sectional side views showingassembly of the sensor applicator 102 with the sensor control device5002, according to one or more embodiments. Once the sensor controldevice 5002 is fully assembled, it may then be loaded into the sensorapplicator 102. With reference to FIG. 21A, the sharp hub 5014 mayinclude or otherwise define a hub snap pawl 5302 configured to helpcouple the sensor control device 5002 to the sensor applicator 102. Morespecifically, the sensor control device 5002 may be advanced into theinterior of the sensor applicator 102 and the hub snap pawl 5302 may bereceived by corresponding arms 5304 of a sharp carrier 5306 positionedwithin the sensor applicator 102.

In FIG. 21B, the sensor control device 5002 is shown received by thesharp carrier 5306 and, therefore, secured within the sensor applicator102. Once the sensor control device 5002 is loaded into the sensorapplicator 102, the applicator cap 210 may be coupled to the sensorapplicator 102. In some embodiments, the applicator cap 210 and thehousing 208 may have opposing, matable sets of threads 5308 that enablethe applicator cap 210 to be screwed onto the housing 208 in a clockwise(or counter-clockwise) direction and thereby secure the applicator cap210 to the sensor applicator 102.

As illustrated, the sheath 212 is also positioned within the sensorapplicator 102, and the sensor applicator 102 may include a sheathlocking mechanism 5310 configured to ensure that the sheath 212 does notprematurely collapse during a shock event. In the illustratedembodiment, the sheath locking mechanism 5310 may comprise a threadedengagement between the applicator cap 210 and the sheath 212. Morespecifically, one or more internal threads 5312 a may be defined orotherwise provided on the inner surface of the applicator cap 210, andone or more external threads 53 12 b may be defined or otherwiseprovided on the sheath 212. The internal and external threads 53 12 a,bmay be configured to threadably mate as the applicator cap 210 isthreaded to the sensor applicator 102 at the threads 5308. The internaland external threads 5312 a,b may have the same thread pitch as thethreads 5308 that enable the applicator cap 210 to be screwed onto thehousing 208.

In FIG. 21C, the applicator cap 210 is shown fully threaded (coupled) tothe housing 208. As illustrated, the applicator cap 210 may furtherprovide and otherwise define a cap post 5314 centrally located withinthe interior of the applicator cap 210 and extending proximally from thebottom thereof. The cap post 5314 may be configured to receive at leasta portion of the sensor cap 5018 as the applicator cap 210 is screwedonto the housing 208.

With the sensor control device 5002 loaded within the sensor applicator102 and the applicator cap 210 properly secured, the sensor controldevice 5002 may then be subjected to a gaseous chemical sterilizationconfigured to sterilize the electronics housing 5004 and any otherexposed portions of the sensor control device 5002. Since the distalportions of the sensor 5010 and the sharp 5012 are sealed within thesensor cap 5018, the chemicals used during the gaseous chemicalsterilization process are unable to interact with the enzymes,chemistry, and biologies provided on the tail 5104, and other sensorcomponents, such as membrane coatings that regulate analyte influx.

FIGS. 22A and 22B are perspective and top views, respectively, of thecap post 5314, according to one or more additional embodiments. In theillustrated depiction, a portion of the sensor cap 5018 is receivedwithin the cap post 5314 and, more specifically, the desiccant cap 5030of the sensor cap 5018 is arranged within cap post 5314.

As illustrated, the cap post 5314 may define a receiver feature 5402configured to receive the engagement feature 5024 of the sensor cap 5018upon coupling (e.g., threading) the applicator cap 210 (FIG. 21C) to thesensor applicator 102 (FIGS. 21A-21C). Upon removing the applicator cap210 from the sensor applicator 102, however, the receiver feature 5402may prevent the engagement feature 5024 from reversing direction andthus prevent the sensor cap 5018 from separating from the cap post 5314.Instead, removing the applicator cap 210 from the sensor applicator 102will simultaneously detach the sensor cap 5018 from the sensor controldevice 5002 (FIGS. 18A-18B and 21A-21C), and thereby expose the distalportions of the sensor 5010 (FIGS. 21A-21C) and the sharp 5012 (FIGS.21A-21C).

Many design variations of the receiver feature 5402 may be employed,without departing from the scope of the disclosure. In the illustratedembodiment, the receiver feature 5402 includes one or more compliantmembers 5404 (two shown) that are expandable or flexible to receive theengagement feature 5024 (FIGS. 18A-18B). The engagement feature 5024 maycomprise, for example, an enlarged head and the compliant member(s) 5404may comprise a collet-type device that includes a plurality of compliantfingers configured to flex radially outward to receive the enlargedhead.

The compliant member(s) 5404 may further provide or otherwise definecorresponding ramped surfaces 5406 configured to interact with one ormore opposing camming surfaces 5408 provided on the outer wall of theengagement feature 5024. The configuration and alignment of the rampedsurface(s) 5406 and the opposing camming surface(s) 5408 is such thatthe applicator cap 210 is able to rotate relative to the sensor cap 5018in a first direction A (e.g., clockwise), but the cap post 5314 bindsagainst the sensor cap 5018 when the applicator cap 210 is rotated in asecond direction B (e.g., counter clockwise). More particularly, as theapplicator cap 210 (and thus the cap post 5314) rotates in the firstdirection A, the camming surfaces 5408 engage the ramped surfaces 5406,which urge the compliant members 5404 to flex or otherwise deflectradially outward and results in a ratcheting effect. Rotating theapplicator cap 210 (and thus the cap post 5314) in the second directionB, however, will drive angled surfaces 5410 of the camming surfaces 5408into opposing angled surfaces 5412 of the ramped surfaces 5406, whichresults in the sensor cap 5018 binding against the compliant member(s)5404.

FIG. 23 is a cross-sectional side view of the sensor control device 5002positioned within the applicator cap 210, according to one or moreembodiments. As illustrated, the opening to the receiver feature 5402exhibits a first diameter D₃, while the engagement feature 5024 of thesensor cap 5018 exhibits a second diameter D₄ that is larger than thefirst diameter D₃ and greater than the outer diameter of the remainingportions of the sensor cap 5018. As the sensor cap 5018 is extended intothe cap post 5314, the compliant member(s) 5404 of the receiver feature5402 may flex (expand) radially outward to receive the engagementfeature 5024. In some embodiments, as illustrated, the engagementfeature 5024 may provide or otherwise define an angled or frustoconicalouter surface that helps bias the compliant member(s) 5404 radiallyoutward. Once the engagement feature 5024 bypasses the receiver feature5402, the compliant member(s) 5404 are able to flex back to (or towards)their natural state and thus lock the sensor cap 5018 within the cappost 5314.

As the applicator cap 210 is threaded to (screwed onto) the housing 208(FIGS. 21A-21C) in the first direction A, the cap post 5314correspondingly rotates in the same direction and the sensor cap 5018 isprogressively introduced into the cap post 5314. As the cap post 5314rotates, the ramped surfaces 5406 of the compliant members 5404 ratchetagainst the opposing camming surfaces 5408 of the sensor cap 5018. Thiscontinues until the applicator cap 210 is fully threaded onto (screwedonto) the housing 208. In some embodiments, the ratcheting action mayoccur over two full revolutions of the applicator cap 210 before theapplicator cap 210 reaches its final position.

To remove the applicator cap 210, the applicator cap 210 is rotated inthe second direction B, which correspondingly rotates the cap post 5314in the same direction and causes the camming surfaces 5408 (i.e., theangled surfaces 5410 of FIGS. 22A-22B) to bind against the rampedsurfaces 5406 (i.e., the angled surfaces 5412 of FIGS. 22A-22B).Consequently, continued rotation of the applicator cap 210 in the seconddirection B causes the sensor cap 5018 to correspondingly rotate in thesame direction and thereby unthread from the mating member 5016 to allowthe sensor cap 5018 to detach from the sensor control device 5002.Detaching the sensor cap 5018 from the sensor control device 5002exposes the distal portions of the sensor 5010 and the sharp 5012, andthus places the sensor control device 5002 in position for firing (use).

FIGS. 24A and 24B are cross-sectional side views of the sensorapplicator 102 ready to deploy the sensor control device 5002 to atarget monitoring location, according to one or more embodiments. Morespecifically, FIG. 24A depicts the sensor applicator 102 ready to deploy(fire) the sensor control device 5002, and FIG. 24B depicts the sensorapplicator 102 in the process of deploying (firing) the sensor controldevice 5002. As illustrated, the applicator cap 210 (FIGS. 21A-21C and23) has been removed, which correspondingly detaches (removes) thesensor cap 5018 (FIGS. 21A-21C and 23) and thereby exposes the tail 5104of the sensor 5010 and the sharp tip 5108 of the sharp 5012, asdescribed above. In conjunction with the sheath 212 and the sharpcarrier 5306, the sensor applicator 102 also includes a sensor carrier5602 (alternately referred to as a “puck” carrier) that helps positionand secure the sensor control device 5002 within the sensor applicator102.

Referring first to FIG. 24A, as illustrated, the sheath 212 includes oneor more sheath arms 5604 (one shown) configured to interact with acorresponding one or more detents 5606 (one shown) defined within theinterior of the housing 208. The detent(s) 5606 are alternately referredto as “firing” detent(s). When the sensor control device 5002 isinitially installed in the sensor applicator 102, the sheath arms 5604may be received within the detents 5606, which places the sensorapplicator 102 in firing position. In the firing position, the matingmember 5016 extends distally beyond the bottom of the sensor controldevice 5002. As discussed below, the process of firing the sensorapplicator 102 causes the mating member 5016 to retract so that it doesnot contact the user's skin.

The sensor carrier 5602 may also include one or more carrier arms 5608(one shown) configured to interact with a corresponding one or moregrooves 5610 (one shown) defined on the sharp carrier 5306. A spring5612 may be arranged within a cavity defined by the sharp carrier 5306and may passively bias the sharp carrier 5306 upward within the housing208. When the carrier arm(s) 5608 are properly received within thegroove(s) 5610, however, the sharp carrier 5306 is maintained inposition and prevented from moving upward. The carrier arm(s) 5608interpose the sheath 212 and the sharp carrier 5306, and a radialshoulder 5614 defined on the sheath 212 may be sized to maintain thecarrier arm(s) 5608 engaged within the groove(s) 5610 and therebymaintain the sharp carrier 5306 in position.

In FIG. 24B, the sensor applicator 102 is in the process of firing. Asdiscussed herein with reference to FIGS. 3F-3G, this may be accomplishedby advancing the sensor applicator 102 toward a target monitoringlocation until the sheath 212 engages the skin of the user. Continuedpressure on the sensor applicator 102 against the skin may cause thesheath arm(s) 5604 to disengage from the corresponding detent(s) 5606,which allows the sheath 212 to collapse into the housing 208. As thesheath 212 starts to collapse, the radial shoulder 5614 eventually movesout of radial engagement with the carrier arm(s) 5608, which allows thecarrier arm(s) 5608 to disengage from the groove(s) 5610. The passivespring force of the spring 5612 is then free to push upward on the sharpcarrier 5306 and thereby force the carrier arm(s) 5608 out of engagementwith the groove(s) 5610, which allows the sharp carrier 5306 to moveslightly upward within the housing 208. In some embodiments, fewer coilsmay be incorporated into the design of the spring 5612 to increase thespring force necessary to overcome the engagement between carrier arm(s)5608 and the groove(s) 5610. In at least one embodiment, one or both ofthe carrier arm(s) 5608 and the groove(s) 5610 may be angled to helpease disengagement.

As the sharp carrier 5306 moves upward within the housing 208, the sharphub 5014 may correspondingly move in the same direction, which may causepartial retraction of the mating member 5016 such that it becomes flush,substantially flush, or sub-flush with the bottom of the sensor controldevice 5002. As will be appreciated, this ensures that the mating member5016 does not come into contact with the user's skin, which mightotherwise adversely impact sensor insertion, cause excessive pain, orprevent the adhesive patch (not shown) positioned on the bottom of thesensor control device 5002 from properly adhering to the skin.

FIGS. 25A-25C are progressive cross-sectional side views showingassembly and disassembly of an alternative embodiment of the sensorapplicator 102 with the sensor control device 5002, according to one ormore additional embodiments. A fully assembled sensor control device5002 may be loaded into the sensor applicator 102 by coupling the hubsnap pawl 5302 into the arms 5304 of the sharp carrier 5306 positionedwithin the sensor applicator 102, as generally described above.

In the illustrated embodiment, the sheath arms 5604 of the sheath 212may be configured to interact with a first detent 5702 a and a seconddetent 5702 b defined within the interior of the housing 208. The firstdetent 5702 a may alternately be referred to a “locking” detent, and thesecond detent 5702 b may alternately be referred to as a “firing”detent. When the sensor control device 5002 is initially installed inthe sensor applicator 102, the sheath arms 5604 may be received withinthe first detent 5702 a. As discussed below, the sheath 212 may beactuated to move the sheath arms 5604 to the second detent 5702 b, whichplaces the sensor applicator 102 in firing position.

In FIG. 25B, the applicator cap 210 is aligned with the housing 208 andadvanced toward the housing 208 so that the sheath 212 is receivedwithin the applicator cap 210. Instead of rotating the applicator cap210 relative to the housing 208, the threads of the applicator cap 210may be snapped onto the corresponding threads of the housing 208 tocouple the applicator cap 210 to the housing 208. Axial cuts or slots5703 (one shown) defined in the applicator cap 210 may allow portions ofthe applicator cap 210 near its threading to flex outward to be snappedinto engagement with the threading of the housing 208. As the applicatorcap 210 is snapped to the housing 208, the sensor cap 5018 maycorrespondingly be snapped into the cap post 5314.

Similar to the embodiment of FIGS. 21A-21C, the sensor applicator 102may include a sheath locking mechanism configured to ensure that thesheath 212 does not prematurely collapse during a shock event. In theillustrated embodiment, the sheath locking mechanism includes one ormore ribs 5704 (one shown) defined near the base of the sheath 212 andconfigured to interact with one or more ribs 5706 (two shown) and ashoulder 5708 defined near the base of the applicator cap 210. The ribs5704 may be configured to inter-lock between the ribs 5706 and theshoulder 5708 while attaching the applicator cap 210 to the housing 208.More specifically, once the applicator cap 210 is snapped onto thehousing 208, the applicator cap 210 may be rotated (e.g., clockwise),which locates the ribs 5704 of the sheath 212 between the ribs 5706 andthe shoulder 5708 of the applicator cap 210 and thereby “locks” theapplicator cap 210 in place until the user reverse rotates theapplicator cap 210 to remove the applicator cap 210 for use. Engagementof the ribs 5704 between the ribs 5706 and the shoulder 5708 of theapplicator cap 210 may also prevent the sheath 212 from collapsingprematurely.

In FIG. 25C, the applicator cap 210 is removed from the housing 208. Aswith the embodiment of FIGS. 21A-21C, the applicator cap 210 can beremoved by reverse rotating the applicator cap 210, whichcorrespondingly rotates the cap post 5314 in the same direction andcauses sensor cap 5018 to unthread from the mating member 5016, asgenerally described above. Moreover, detaching the sensor cap 5018 fromthe sensor control device 5002 exposes the distal portions of the sensor5010 and the sharp 5012.

As the applicator cap 210 is unscrewed from the housing 208, the ribs5704 defined on the sheath 212 may slidingly engage the tops of the ribs5706 defined on the applicator cap 210. The tops of the ribs 5706 mayprovide corresponding ramped surfaces that result in an upwarddisplacement of the sheath 212 as the applicator cap 210 is rotated, andmoving the sheath 212 upward causes the sheath arms 5604 to flex out ofengagement with the first detent 5702 a to be received within the seconddetent 5702 b. As the sheath 212 moves to the second detent 5702 b, theradial shoulder 5614 moves out of radial engagement with the carrierarm(s) 5608, which allows the passive spring force of the spring 5612 topush upward on the sharp carrier 5306 and force the carrier arm(s) 5608out of engagement with the groove(s) 5610. As the sharp carrier 5306moves upward within the housing 208, the mating member 5016 maycorrespondingly retract until it becomes flush, substantially flush, orsub-flush with the bottom of the sensor control device 5002. At thispoint, the sensor applicator 102 in firing position. Accordingly, inthis embodiment, removing the applicator cap 210 correspondingly causesthe mating member 5016 to retract.

FIG. 26A is an isometric bottom view of the housing 208, according toone or more embodiments. As illustrated, one or more longitudinal ribs5802 (four shown) may be defined within the interior of the housing 208.The ribs 5802 may be equidistantly or non-equidistantly spaced from eachother and extend substantially parallel to centerline of the housing208. The first and second detents 5702 a, b may be defined on one ormore of the longitudinal ribs 5802.

FIG. 27A is an isometric bottom view of the housing 208 with the sheath212 and other components at least partially positioned within thehousing 208. As illustrated, the sheath 212 may provide or otherwisedefine one or more longitudinal slots 5804 configured to mate with thelongitudinal ribs 5802 of the housing 208. As the sheath 212 collapsesinto the housing 208, as generally described above, the ribs 5802 may bereceived within the slots 5804 to help maintain the sheath 212 alignedwith the housing during its movement. As will be appreciated, this mayresult in tighter circumferential and radial alignment within the samedimensional and tolerance restrictions of the housing 208.

In the illustrated embodiment, the sensor carrier 5602 may be configuredto hold the sensor control device 5002 in place both axially (e.g., oncethe sensor cap 5018 is removed) and circumferentially. To accomplishthis, the sensor carrier 5602 may include or otherwise define one ormore support ribs 5806 and one or more flexible arms 5808. The supportribs 5806 extend radially inward to provide radial support to the sensorcontrol device 5002. The flexible arms 5808 extend partially about thecircumference of the sensor control device 5002 and the ends of theflexible arms 5808 may be received within corresponding grooves 5810defined in the side of the sensor control device 5002. Accordingly, theflexible arms 5808 may be able to provide both axial and radial supportto the sensor control device 5002. In at least one embodiment, the endsof the flexible arms 5808 may be biased into the grooves 5810 of thesensor control device 5002 and otherwise locked in place withcorresponding sheath locking ribs 5812 provided by the sheath 212.

In some embodiments, the sensor carrier 5602 may be ultrasonicallywelded to the housing 208 at one or more points 5814. In otherembodiments, however, the sensor carrier 5602 may alternatively becoupled to the housing 208 via a snap-fit engagement, without departingfrom the scope of the disclosure. This may help hold the sensor controldevice 5002 in place during transport and firing.

FIG. 28 is an enlarged cross-sectional side view of the sensorapplicator 102 with the sensor control device 5002 installed therein,according to one or more embodiments. As discussed above, the sensorcarrier 5602 may include one or more carrier arms 5608 (two shown)engageable with the sharp carrier 5306 at corresponding grooves 5610. Inat least one embodiment, the grooves 5610 may be defined by pairs ofprotrusions 5902 defined on the sharp carrier 5306. Receiving thecarrier arms 5608 within the grooves 5610 may help stabilize the sharpcarrier 5306 from unwanted tilting during all stages of retraction(firing).

In the illustrated embodiment, the arms 5304 of the sharp carrier 5306may be stiff enough to control, with greater refinement, radial andbi-axial motion of the sharp hub 5014. In some embodiments, for example,clearances between the sharp hub 5014 and the arms 5304 may be morerestrictive in both axial directions as the relative control of theheight of the sharp hub 5014 may be more critical to the design.

In the illustrated embodiment, the sensor carrier 5602 defines orotherwise provides a central boss 5904 sized to receive the sharp hub5014. In some embodiments, as illustrated, the sharp hub 5014 mayprovide one or more radial ribs 5906 (two shown). In at least oneembodiment, the inner diameter of the central boss 5904 helps provideradial and tilt support to the sharp hub 5014 during the life of sensorapplicator 102 and through all phases of operation and assembly.Moreover, having multiple radial ribs 5906 increases the length-to-widthratio of the sharp hub 5014, which also improves support againsttilting.

FIG. 29A is an isometric top view of the applicator cap 210, accordingto one or more embodiments. In the illustrated embodiment, two axialslots 5703 are depicted that separate upper portions of the applicatorcap 210 near its threading. As mentioned above, the slots 5703 may helpthe applicator cap 210 flex outward to be snapped into engagement withthe housing 208 (FIG. 25B). In contrast, the applicator cap 210 may betwisted (unthreaded) off the housing 208 by an end user.

FIG. 29A also depicts the ribs 5706 (one visible) defined by theapplicator cap 210. By interlocking with the ribs 5704 (FIG. 25C)defined on the sheath 212 (FIG. 25C), the ribs 5706 may help lock thesheath 212 in all directions to prevent premature collapse during ashock or drop event. The sheath 212 may be unlocked when the userunscrews the applicator cap 210 from the housing, as generally describedabove. As mentioned herein, the top of each rib 5706 may provide acorresponding ramped surface 6002, and as the applicator cap 210 isrotated to unthread from the housing 208, the ribs 5704 defined on thesheath 212 may slidingly engage the ramped surfaces 6002, which resultsin the upward displacement of the sheath 212 into the housing 208.

In some embodiments, additional features may be provided within theinterior of the applicator cap 210 to hold a desiccant component thatmaintains proper moisture levels through shelf life. Such additionalfeatures may be snaps, posts for press-fitting, heat-staking, ultrasonicwelding, etc.

FIG. 29B is an enlarged cross-sectional view of the engagement betweenthe applicator cap 210 and the housing 208, according to one or moreembodiments. As illustrated, the applicator cap 210 may define a set ofinner threads 6004 and the housing 208 may define a set of outer threads6006 engageable with the inner threads 6004. As mentioned herein, theapplicator cap 210 may be snapped onto the housing 208, which may beaccomplished by advancing the inner threads 6004 axially past the outerthreads 6006 in the direction indicated by the arrow, which causes theapplicator cap 210 to flex outward. To help ease this transition, asillustrated, corresponding surfaces 6008 of the inner and outer threads6004, 6006 may be curved, angled, or chamfered. Corresponding flatsurfaces 6010 may be provided on each thread 6004, 6006 and configuredto matingly engage once the applicator cap 210 is properly snapped intoplace on the housing 208. The flat surfaces 6010 may slidingly engageone another as the user unthreads the applicator cap 210 from thehousing 208.

The threaded engagement between the applicator cap 210 and the housing208 results in a sealed engagement that protects the inner componentsagainst moisture, dust, etc. In some embodiments, the housing 208 maydefine or otherwise provide a stabilizing feature 6012 configured to bereceived within a corresponding groove 6014 defined on the applicatorcap 210. The stabilizing feature 6012 may help stabilize and stiffen theapplicator cap 210 once the applicator cap 210 is snapped onto thehousing 208. This may prove advantageous in providing additional droprobustness to the sensor applicator 102. This may also help increase theremoval torque of the applicator cap 210.

FIGS. 30A and 30B are isometric views of the sensor cap 5018 and thecollar 5112, respectively, according to one or more embodiments.Referring to FIG. 30A, in some embodiments, the sensor cap 5018 maycomprise an injection molded part. This may prove advantageous inmolding the internal threads 5026 a defined within the inner chamber5022, as opposed to installing a threaded core or threading the innerchamber 5022. In some embodiments, one or more stop ribs 6102 (onvisible) may be defined within the inner chamber 5022 to prevent overtravel relative to mating member 5016 of the sharp hub 5014 (FIGS.18A-18B).

Referring to both FIGS. 30A and 30B, in some embodiments, one or moreprotrusions 6104 (two shown) may be defined on the first end 5020 a ofthe sensor cap 5018 and configured to mate with one or morecorresponding indentations 6106 (two shown) defined on the collar 5112.In other embodiments, however, the protrusions 6104 may instead bedefined on the collar 5112 and the indentations 6106 may be defined onthe sensor cap 5018, without departing from the scope of the disclosure.

The matable protrusions 6104 and indentations 6106 may proveadvantageous in rotationally locking the sensor cap 5018 to preventunintended unscrewing of the sensor cap 5018 from the collar 5112 (andthus the sensor control device 5002) during the life of the sensorapplicator 102 and through all phases of operation/assembly. In someembodiments, as illustrated, the indentations 6106 may be formed orotherwise defined in the general shape of a kidney bean. This may proveadvantageous in allowing for some over-rotation of the sensor cap 5018relative to the collar 5112. Alternatively, the same benefit may beachieved via a flat end threaded engagement between the two parts.

Embodiments disclosed herein include:

A. A sensor control device that includes an electronics housing, asensor arranged within the electronics housing and having a tailextending from a bottom of the electronics housing, a sharp extendingthrough the electronics housing and having a sharp tip extending fromthe bottom of the electronics housing, and a sensor cap removablycoupled at the bottom of the electronics housing and defining a sealedinner chamber that receives the tail and the sharp.

B. An analyte monitoring system that includes a sensor applicator, asensor control device positioned within the sensor applicator andincluding an electronics housing, a sensor arranged within theelectronics housing and having a tail extending from a bottom of theelectronics housing, a sharp extending through the electronics housingand having a sharp tip extending from the bottom of the electronicshousing, and a sensor cap removably coupled at the bottom of theelectronics housing and defining an engagement feature and a sealedinner chamber that receives the tail and the sharp. The analytemonitoring system may further include a cap coupled to the sensorapplicator and providing a cap post defining a receiver feature thatreceives the engagement feature upon coupling the cap to the sensorapplicator, wherein removing the cap from the sensor applicator detachesthe sensor cap from the electronics housing and thereby exposes the tailand the sharp tip.

C. A method of preparing an analyte monitoring system that includesloading a sensor control device into a sensor applicator, the sensorcontrol device including an electronics housing, a sensor arrangedwithin the electronics housing and having a tail extending from a bottomof the electronics housing, a sharp extending through the electronicshousing and having a sharp tip extending from the bottom of theelectronics housing, and a sensor cap removably coupled at the bottom ofthe electronics housing and defining a sealed inner chamber thatreceives the tail and the sharp. The method further including securing acap to the sensor applicator, sterilizing the sensor control device withgaseous chemical sterilization while the sensor control device ispositioned within the sensor applicator, and isolating the tail and thesharp tip within the inner chamber from the gaseous chemicalsterilization.

Each of embodiments A, B, and C may have one or more of the followingadditional elements in any combination: Element 1: wherein the sensorcap comprises a cylindrical body having a first end that is open toaccess the inner chamber, and a second end opposite the first end andproviding an engagement feature engageable with a cap of a sensorapplicator, wherein removing the cap from the sensor applicatorcorrespondingly removes the sensor cap from the electronics housing andthereby exposes the tail and the sharp tip. Element 2: wherein theelectronics housing includes a shell matable with a mount, the sensorcontrol device further comprising a sharp and sensor locator defined onan inner surface of the shell, and a collar received about the sharp andsensor locator, wherein the sensor cap is removably coupled to thecollar. Element 3: wherein the sensor cap is removably coupled to thecollar by one or more of an interference fit, a threaded engagement, afrangible member, and a frangible substance. Element 4: wherein anannular ridge circumscribes the sharp and sensor locator and the collarprovides a column and an annular shoulder extending radially outwardfrom the column, and wherein a seal member interposes the annularshoulder and the annular ridge to form a sealed interface. Element 5:wherein the annular ridge defines a groove and a portion of the sensoris seated within the groove, and wherein the seal member extends intothe groove to seal about the portion of the sensor. Element 6: whereinthe seal member is a first seal member, the sensor control devicefurther comprising a second seal member interposing the annular shoulderand a portion of the mount to form a sealed interface. Element 7:wherein the electronics housing includes a shell matable with a mount,the sensor control device further comprising a sharp hub that carriesthe sharp and is engageable with a top surface of the shell, and amating member defined by the sharp hub and extending from the bottom ofthe electronics housing, wherein the sensor cap is removably coupled tothe mating member. Element 8: further comprising a collar at leastpartially receivable within an aperture defined in the mount andsealingly engaging the sensor cap and an inner surface of the shell.Element 9: wherein a seal member interposes the collar and the innersurface of the shell to form a sealed interface. Element 10: wherein thecollar defines a groove and a portion of the sensor is seated within thegroove, and wherein the seal member extends into the groove to sealabout the portion of the sensor.

Element 11: wherein the receiver feature comprises one or more compliantmembers that flex to receive the engagement feature, and wherein the oneor more compliant members prevent the engagement feature from exitingthe cap post upon removing the cap from the sensor applicator. Element12: further comprising a ramped surface defined on at least one of theone or more compliant members, and one or more camming surfaces providedby the engagement feature and engageable with the ramped surface,wherein the ramped surface and the one or more camming surfaces allowthe cap and the cap post to rotate relative to the sensor cap in a firstdirection, but prevent the cap and the cap post from rotating relativeto the sensor cap in a second direction opposite the first direction.Element 13: wherein the electronics housing includes a shell matablewith a mount, the sensor control device further comprising a sharp hubthat carries the sharp and is engageable with a top surface of theshell, and a mating member defined by the sharp hub and extending fromthe bottom of the electronics housing, wherein the sensor cap isremovably coupled to the mating member and rotating the cap in thesecond direction detaches the sensor cap from the mating member. Element14: wherein the electronics housing includes a shell matable with amount and the sensor control device further includes a sharp and sensorlocator defined on an inner surface of the shell, and a collar receivedabout the sharp and sensor locator, wherein the sensor cap is removablycoupled to the collar.

Element 15: wherein the cap provides a cap post defining a receiverfeature and the sensor cap defines an engagement feature, the methodfurther comprising receiving the engagement feature with the receiverfeature as the cap is secured to the sensor applicator. Element 16:further comprising removing the cap from the sensor applicator, andengaging the engagement feature on the receiver feature as the cap isbeing removed and thereby detaching the sensor cap from the electronicshousing and exposing the tail and the sharp tip. Element 17: whereinloading the sensor control device into a sensor applicator is precededby sterilizing the tail and the sharp tip with radiation sterilization,and sealing the tail and the sharp tip within the inner chamber.

By way of non-limiting example, exemplary combinations applicable to A,B, and C include: Element 2 with Element 3; Element 2 with Element 4;Element 4 with Element 5; Element 4 with Element 6; Element 7 withElement 8; Element 8 with Element 9; Element 9 with Element 10; Element11 with Element 12; and Element 15 with Element 16.

Example Embodiments of Seal Arrangement for Analyte Monitoring Systems

FIGS. 31A and 31B are side and isometric views, respectively, of anexample sensor control device 9102, according to one or more embodimentsof the present disclosure. The sensor control device 9102 may be similarin some respects to the sensor control device 102 of FIG. 1 andtherefore may be best understood with reference thereto. Moreover, thesensor control device 9102 may replace the sensor control device 102 ofFIG. 1 and, therefore, may be used in conjunction with the sensorapplicator 102 of FIG. 1, which may deliver the sensor control device9102 to a target monitoring location on a user's skin.

As illustrated, the sensor control device 9102 includes an electronicshousing 9104, which may be generally disc-shaped and have a circularcross-section. In other embodiments, however, the electronics housing9104 may exhibit other cross-sectional shapes, such as ovoid, oval, orpolygonal, without departing from the scope of the disclosure. Theelectronics housing 9104 includes a shell 9106 and a mount 9108 that ismatable with the shell 9106. The shell 9106 may be secured to the mount9108 via a variety of ways, such as a snap fit engagement, aninterference fit, sonic welding, laser welding, one or more mechanicalfasteners (e.g., screws), a gasket, an adhesive, or any combinationthereof. In some cases, the shell 9106 may be secured to the mount 9108such that a sealed interface is generated therebetween. An adhesivepatch 9110 may be positioned on and otherwise attached to the undersideof the mount 9108. Similar to the adhesive patch 108 of FIG. 1, theadhesive patch 9110 may be configured to secure and maintain the sensorcontrol device 9102 in position on the user's skin during operation.

The sensor control device 9102 may further include a sensor 9112 and asharp 9114 used to help deliver the sensor 9112 transcutaneously under auser's skin during application of the sensor control device 9102.Corresponding portions of the sensor 9112 and the sharp 9114 extenddistally from the bottom of the electronics housing 9104 (e.g., themount 9108). A sharp hub 9116 may be overmolded onto the sharp 9114 andconfigured to secure and carry the sharp 9114. As best seen in FIG. 31A,the sharp hub 9116 may include or otherwise define a mating member 9118.In assembling the sharp 9114 to the sensor control device 9102, thesharp 9114 may be advanced axially through the electronics housing 9104until the sharp hub 9116 engages an upper surface of the electronicshousing 9104 or an internal component thereof and the mating member 9118extends distally from the bottom of the mount 9108. As described hereinbelow, in at least one embodiment, the sharp hub 9116 may sealinglyengage an upper portion of a seal overmolded onto the mount 9108. As thesharp 9114 penetrates the electronics housing 9104, the exposed portionof the sensor 9112 may be received within a hollow or recessed (arcuate)portion of the sharp 9114. The remaining portion of the sensor 9112 isarranged within the interior of the electronics housing 9104.

The sensor control device 9102 may further include a sensor cap 9120,shown detached from the electronics housing 9104 in FIGS. 31A-31B. Thesensor cap 9120 may help provide a sealed barrier that surrounds andprotects exposed portions of the sensor 9112 and the sharp 9114. Asillustrated, the sensor cap 9120 may comprise a generally cylindricalbody having a first end 9122 a and a second end 9122 b opposite thefirst end 9122 a. The first end 9122 a may be open to provide accessinto an inner chamber 9124 defined within the body. In contrast, thesecond end 9122 b may be closed and may provide or otherwise define anengagement feature 9126. As described in more detail below, theengagement feature 9126 may help mate the sensor cap 9120 to anapplicator cap of a sensor applicator (e.g., the sensor applicator 102of FIG. 1), and may help remove the sensor cap 9120 from the sensorcontrol device 9102 upon removing the sensor cap from the sensorapplicator.

The sensor cap 9120 may be removably coupled to the electronics housing9104 at or near the bottom of the mount 9108. More specifically, thesensor cap 9120 may be removably coupled to the mating member 9118,which extends distally from the bottom of the mount 9108. In at leastone embodiment, for example, the mating member 9118 may define a set ofexternal threads 9128 a (FIG. 31A) matable with a set of internalthreads 9128 b (FIG. 31B) defined within the inner chamber 9124 of thesensor cap 9120. In some embodiments, the external and internal threads9128 a,b may comprise a flat thread design (e.g., lack of helicalcurvature), but may alternatively comprise a helical threadedengagement. Accordingly, in at least one embodiment, the sensor cap 9120may be threadably coupled to the sensor control device 9102 at themating member 9118 of the sharp hub 9116. In other embodiments, thesensor cap 9120 may be removably coupled to the mating member 9118 viaother types of engagements including, but not limited to, aninterference or friction fit, or a frangible member or substance (e.g.,wax, an adhesive, etc.) that may be broken with minimal separation force(e.g., axial or rotational force).

In some embodiments, the sensor cap 9120 may comprise a monolithic(singular) structure extending between the first and second ends 9122a,b. In other embodiments, however, the sensor cap 9120 may comprise twoor more component parts. In the illustrated embodiment, for example, thebody of the sensor cap 9120 may include a desiccant cap 9130 arranged atthe second end 9122 b. The desiccant cap 9130 may house or comprise adesiccant to help maintain preferred humidity levels within the innerchamber 9124. Moreover, the desiccant cap 9130 may also define orotherwise provide the engagement feature 9126 of the sensor cap 9120. Inat least one embodiment, the desiccant cap 9130 may comprise anelastomeric plug inserted into the bottom end of the sensor cap 9120.

FIGS. 32A and 32B are exploded, isometric top and bottom views,respectively, of the sensor control device 9102, according to one ormore embodiments. The shell 9106 and the mount 9108 operate as opposingclamshell halves that enclose or otherwise substantially encapsulatevarious electronic components (not shown) of the sensor control device9102. Example electronic components that may be arranged between theshell 9106 and the mount 9108 include, but are not limited to, abattery, resistors, transistors, capacitors, inductors, diodes, andswitches.

The shell 9106 may define a first aperture 9202 a and the mount 9108 maydefine a second aperture 9202 b, and the apertures 9202 a, b may alignwhen the shell 9106 is properly mounted to the mount 9108. As best seenin FIG. 32A, the mount 9108 may provide or otherwise define a pedestal9204 that protrudes from the inner surface of the mount 9108 at thesecond aperture 9202 b. The pedestal 9204 may define at least a portionof the second aperture 9202 b. Moreover, a channel 9206 may be definedon the inner surface of the mount 9108 and may circumscribe the pedestal9202. In the illustrated embodiment, the channel 9206 is circular inshape, but could alternatively be another shape, such as oval, ovoid, orpolygonal.

The mount 9108 may comprise a molded part made of a rigid material, suchas plastic or metal. In some embodiments, a seal 9208 may be overmoldedonto the mount 9108 and may be made of an elastomer, rubber, a-polymer,or another pliable material suitable for facilitating a sealedinterface. In embodiments where the mount 9108 is made of a plastic, themount 9108 may be molded in a first “shot” of injection molding, and theseal 9208 may be overmolded onto the mount 9108 in a second “shot” ofinjection molding. Accordingly, the mount 9108 may be referred to orotherwise characterized as a “two-shot mount.”

In the illustrated embodiment, the seal 9208 may be overmolded onto themount 9108 at the pedestal 9204 and also on the bottom of the mount9108. More specifically, the seal 9208 may define or otherwise provide afirst seal element 9210 a overmolded onto the pedestal 9204, and asecond seal element 9210 b (FIG. 32B) interconnected to (with) the firstseal element 9210 a and overmolded onto the mount 9108 at the bottom ofthe mount 9108. In some embodiments, one or both of the seal elements9210 a,b may help form corresponding portions (sections) of the secondaperture 9202 b. While the seal 9208 is described herein as beingovermolded onto the mount 9108, it is also contemplated herein that oneor both of the seal elements 9210 a,b may comprise an elastomericcomponent part independent of the mount 9208, such as an O-ring or agasket.

The sensor control device 9102 may further include a collar 9212, whichmay be a generally annular structure that defines a central aperture9214. The central aperture 9214 may be sized to receive the first sealelement 9210 a and may align with both the first and second apertures9202 a, b when the sensor control device 9102 is properly assembled. Theshape of the central aperture 9214 may generally match the shape of thesecond aperture 9202 b and the first seal element 9210 a.

In some embodiments, the collar 9212 may define or otherwise provide anannular lip 9216 on its bottom surface. The annular lip 9216 may besized and otherwise configured to mate with or be received into thechannel 9206 defined on the inner surface of the mount 9108. In someembodiments, a groove 9218 may be defined on the annular lip 9216 andmay be configured to accommodate or otherwise receive a portion of thesensor 9112 extending laterally within the mount 9108. In someembodiments, the collar 9212 may further define or otherwise provide acollar channel 9220 (FIG. 32A) on its upper surface sized to receive andotherwise mate with an annular ridge 9222 (FIG. 32B) defined on theinner surface of the shell 9106 when the sensor control device 9102 isproperly assembled.

The sensor 9112 may include a tail 9224 that extends through the secondaperture 9202 b defined in the mount 9108 to be transcutaneouslyreceived beneath a user's skin. The tail 9224 may have an enzyme orother chemistry included thereon to help facilitate analyte monitoring.The sharp 9114 may include a sharp tip 9226 extendable through the firstaperture 9202 a defined by the shell 9106. As the sharp tip 9226penetrates the electronics housing 9104, the tail 9224 of the sensor9112 may be received within a hollow or recessed portion of the sharptip 9226. The sharp tip 9226 may be configured to penetrate the skinwhile carrying the tail 9224 to put the active chemistry of the tail9224 into contact with bodily fluids.

The sensor control device 9102 may provide a sealed subassembly thatincludes, among other component parts, portions of the shell 9106, thesensor 9112, the sharp 9114, the seal 9208, the collar 9212, and thesensor cap 9120. The sealed subassembly may help isolate the sensor 9112and the sharp 9114 within the inner chamber 9124 (FIG. 32A) of thesensor cap 9120. In assembling the sealed subassembly, the sharp tip9226 is advanced through the electronics housing 9104 until the sharphub 9116 engages the seal 9208 and, more particularly, the first sealelement 9210 a. The mating member 9118 provided at the bottom of thesharp hub 9116 may extend out the second aperture 9202 b in the bottomof the mount 9108, and the sensor cap 9120 may be coupled to the sharphub 9116 at the mating member 9118. Coupling the sensor cap 9120 to thesharp hub 9116 at the mating member 9118 may urge the first end 9122 aof the sensor cap 9120 into sealed engagement with the seal 9208 and,more particularly, into sealed engagement with the second seal element9210 b on the bottom of the mount 9108. In some embodiments, as thesensor cap 9120 is coupled to the sharp hub 9116, a portion of the firstend 9122 a of the sensor cap 9120 may bottom out (engage) against thebottom of the mount 9108, and the sealed engagement between the sensorhub 9116 and the first seal element 9210 a may be able to assume anytolerance variation between features.

FIG. 33 is a cross-sectional side view of the sensor control device9102, according to one or more embodiments. As indicated above, thesensor control device 9102 may include or otherwise incorporate a sealedsubassembly 9302, which may be useful in isolating the sensor 9112 andthe sharp 9114 within the inner chamber 9124 of the sensor cap 9120. Toassemble the sealed subassembly 9302, the sensor 9112 may be locatedwithin the mount 9108 such that the tail 9224 extends through the secondaperture 9202 b at the bottom of the mount 9108. In at least oneembodiment, a locating feature 9304 may be defined on the inner surfaceof the mount 9108, and the sensor 9112 may define a groove 9306 that ismatable with the locating feature 9304 to properly locate the sensor9112 within the mount 9108.

Once the sensor 9112 is properly located, the collar 9212 may beinstalled on the mount 9108. More specifically, the collar 9212 may bepositioned such that the first seal element 9210 a of the seal 9208 isreceived within the central aperture 9214 defined by the collar 9212 andthe first seal element 9210 a generates a radial seal against the collar9212 at the central aperture 9214. Moreover, the annular lip 9216defined on the collar 9212 may be received within the channel 9206defined on the mount 9108, and the groove 9218 defined through theannular lip 9216 may be aligned to receive the portion of the sensor9112 that traverses the channel 9206 laterally within the mount 9108. Insome embodiments, an adhesive may be injected into the channel 9206 tosecure the collar 9212 to the mount 9108. The adhesive may alsofacilitate a sealed interface between the two components and generate aseal around the sensor 9112 at the groove 9218, which may isolate thetail 9224 from the interior of the electronics housing 9104.

The shell 9106 may then be mated with or otherwise coupled to the mount9108. In some embodiments, as illustrated, the shell 9106 may mate withthe mount 9108 via a tongue-and-groove engagement 9308 at the outerperiphery of the electronics housing 9104. An adhesive may be injected(applied) into the groove portion of the engagement 9308 to secure theshell 9106 to the mount 9108, and also to create a sealed engagementinterface. Mating the shell 9106 to the mount 9108 may also cause theannular ridge 9222 defined on the inner surface of the shell 9106 to bereceived within the collar channel 9220 defined on the upper surface ofthe collar 9212. In some embodiments, an adhesive may be injected intothe collar channel 9220 to secure the shell 9106 to the collar 9212, andalso to facilitate a sealed interface between the two components at thatlocation. When the shell 9106 mates with the mount 9108, the first sealelement 9210 a may extend at least partially through (into) the firstaperture 9202 a defined in the shell 9106.

The sharp 9114 may then be coupled to the sensor control device 9102 byextending the sharp tip 9226 through the aligned first and secondapertures 9202 a, b defined in the shell 9106 and the mount 9108,respectively. The sharp 9114 may be advanced until the sharp hub 9116engages the seal 9208 and, more particularly, engages the first sealelement 9210 a. The mating member 9118 may extend (protrude) out thesecond aperture 9202 b at the bottom of the mount 9108 when the sharphub 9116 engages the first seal element 9210 a.

The sensor cap 9120 may then be removably coupled to the sensor controldevice 9102 by threadably mating the internal threads 9128 b of thesensor cap 9120 with the external threads 9128 a of the mating member9118. The inner chamber 9124 may be sized and otherwise configured toreceive the tail 9224 and the sharp tip 9226 extending from the bottomof the mount 9108. Moreover, the inner chamber 9124 may be sealed toisolate the tail 9224 and the sharp tip 9226 from substances that mightadversely interact with the chemistry of the tail 9224. In someembodiments, a desiccant (not shown) may be present within the innerchamber 9124 to maintain proper humidity levels.

Tightening (rotating) the mated engagement between the sensor cap 9120and the mating member 9118 may urge the first end 9122 a of the sensorcap 9120 into sealed engagement with the second seal element 9210 b inan axial direction (e.g., along the centerline of the apertures 9202 a,b), and may further enhance the sealed interface between the sharp hub9116 and the first seal element 9210 a in the axial direction. Moreover,tightening the mated engagement between the sensor cap 9120 and themating member 9118 may compress the first seal element 9210 a, which mayresult in an enhanced radial sealed engagement between the first sealelement 9210 a and the collar 9212 at the central aperture 9214.Accordingly, in at least one embodiment, the first seal element 9210 amay help facilitate axial and radial sealed engagements.

As mentioned above, the first and second seal elements 9210 a,b may beovermolded onto the mount 9108 and may be physically linked or otherwiseinterconnected. Consequently, a single injection molding shot may flowthrough the second aperture 9202 b of the mount 9108 to create both endsof the seal 9208. This may prove advantageous in being able to generatemultiple sealed interfaces with only a single injection molded shot. Anadditional advantage of a two-shot molded design, as opposed to usingseparate elastomeric components (e.g., O-rings, gaskets, etc.), is thatthe interface between the first and second shots is a reliable bondrather than a mechanical seal. Hence, the effective number of mechanicalsealing barriers is effectively cut in half. Moreover, a two-shotcomponent with a single elastomeric shot also has implications tominimizing the number of two-shot components needed to achieve all thenecessary sterile barriers. Once properly assembled, the sealedsubassembly 9302 may be subjected to a radiation sterilization processto sterilize the sensor 9112 and the sharp 9114. The sealed subassembly9302 may be subjected to the radiation sterilization prior to or aftercoupling the sensor cap 9120 to the sharp hub 9116. When sterilizedafter coupling the sensor cap 9120 to the sharp hub 9116, the sensor cap9120 may be made of a material that permits the propagation of radiationtherethrough. In some embodiments, the sensor cap 9120 may betransparent or translucent, but can otherwise be opaque, withoutdeparting from the scope of the disclosure.

FIG. 33A is an exploded isometric view of a portion of anotherembodiment of the sensor control device 9102 of FIGS. 31A-31B and32A-32B. Embodiments included above describe the mount 9108 and the seal9208 being manufactured via a two-shot injection molding process. Inother embodiments, however, as briefly mentioned above, one or both ofthe seal elements 9210 a,b of the seal 9208 may comprise an elastomericcomponent part independent of the mount 9208. In the illustratedembodiment, for example, the first seal element 9210 a may be overmoldedonto the collar 9212 and the second seal element 9210 b may beovermolded onto the sensor cap 9120. Alternatively, the first and secondseal elements 9210 a,b may comprise a separate component part, such as agasket or O-ring positioned on the collar 9212 and the sensor cap 9120,respectively. Tightening (rotating) the mated engagement between thesensor cap 9120 and the mating member 9118 may urge the second sealelement 9210 b into sealed engagement with the bottom of the mount 9108in an axial direction, and may enhance a sealed interface between thesharp hub 9116 and the first seal element 9210 a in the axial direction.

FIG. 34A is an isometric bottom view of the mount 9108, and FIG. 34B isan isometric top view of the sensor cap 9120, according to one or moreembodiments. As shown in FIG. 34A, the mount 9108 may provide orotherwise define one or more indentations or pockets 9402 at or near theopening to the second aperture 9202 b. As shown in FIG. 34B, the sensorcap 9120 may provide or otherwise define one or more projections 9404 ator near the first end 9122 a of the sensor cap 9120. The projections9404 may be received within the pockets 9402 when the sensor cap 9120 iscoupled to the sharp hub 9116 (FIGS. 32A-32B and 93). More specifically,as described above, as the sensor cap 9120 is coupled to the matingmember 9118 (FIGS. 32A-32B and 93) of the sensor hub 9116, the first end9122 a of the sensor cap 9120 is brought into sealed engagement with thesecond seal element 9210 b. In this process, the projections 9404 mayalso be received within the pockets 9402, which may help preventpremature unthreading of the sensor cap 9120 from the sharp hub 9116.

FIGS. 35A and 35B are side and cross-sectional side views, respectively,of an example sensor applicator 9502, according to one or moreembodiments. The sensor applicator 9502 may be similar in some respectsto the sensor applicator 102 of FIG. 1 and, therefore, may be designedto deliver (fire) a sensor control device, such as the sensor controldevice 9102. FIG. 35A depicts how the sensor applicator 9502 might beshipped to and received by a user, and FIG. 35B depicts the sensorcontrol device 9102 arranged within the interior of the sensorapplicator 9502.

As shown in FIG. 35A, the sensor applicator 9502 includes a housing 9504and an applicator cap 9506 removably coupled to the housing 9504. Insome embodiments, the applicator cap 9506 may be threaded to the housing9504 and include a tamper ring 9508. Upon rotating (e.g., unscrewing)the applicator cap 9506 relative to the housing 9504, the tamper ring9508 may shear and thereby free the applicator cap 9506 from the sensorapplicator 9502.

In FIG. 35B, the sensor control device 9102 is positioned within thesensor applicator 9502. Once the sensor control device 9102 is fullyassembled, it may then be loaded into the sensor applicator 9502 and theapplicator cap 9506 may be coupled to the sensor applicator 9502. Insome embodiments, the applicator cap 9506 and the housing 9504 may haveopposing, matable sets of threads that enable the applicator cap 9506 tobe screwed onto the housing 9504 in a clockwise (or counter-clockwise)direction and thereby secure the applicator cap 9506 to the sensorapplicator 9502.

Securing the applicator cap 9506 to the housing 9504 may also cause thesecond end 9122 b of the sensor cap 9120 to be received within a cappost 9510 located within the interior of the applicator cap 9506 andextending proximally from the bottom thereof. The cap post 9510 may beconfigured to receive at least a portion of the sensor cap 9120 as theapplicator cap 9506 is coupled to the housing 9504.

FIGS. 36A and 36B are perspective and top views, respectively, of thecap post 9510, according to one or more additional embodiments. In theillustrated depiction, a portion of the sensor cap 9120 is receivedwithin the cap post 9510 and, more specifically, the desiccant cap 9130of the sensor cap 9120 is arranged within cap post 9510. The cap post9510 may define a receiver feature 9602 configured to receive theengagement feature 9126 of the sensor cap 9120 upon coupling (e.g.,threading) the applicator cap 9506 (FIG. 35B) to the sensor applicator9502 (FIGS. 35A-35B). Upon removing the applicator cap 9506 from thesensor applicator 9502, however, the receiver feature 9602 may preventthe engagement feature 9126 from reversing direction and thus preventthe sensor cap 9120 from separating from the cap post 9510. Instead,removing the applicator cap 9506 from the sensor applicator 9502 willsimultaneously detach the sensor cap 9120 from the sensor control device9102 (FIGS. 31A-31B and 32A-32B), and thereby expose the distal portionsof the sensor 9112 (FIGS. 32A-32B) and the sharp 9114 (FIGS. 32A-32B).

Many design variations of the receiver feature 9602 may be employed,without departing from the scope of the disclosure. In the illustratedembodiment, the receiver feature 9602 includes one or more compliantmembers 9604 (two shown) that are expandable or flexible to receive theengagement feature 9126. The engagement feature 9126 may comprise, forexample, an enlarged head and the compliant member(s) 9604 may comprisea collet-type device that includes a plurality of compliant fingersconfigured to flex radially outward to receive the enlarged head.

The compliant member(s) 9604 may further provide or otherwise definecorresponding ramped surfaces 9606 configured to interact with one ormore opposing camming surfaces 9608 provided on the outer wall of theengagement feature 9126. The configuration and alignment of the rampedsurface(s) 9606 and the opposing camming surface(s) 9608 is such thatthe applicator cap 9506 is able to rotate relative to the sensor cap9120 in a first direction A (e.g., clockwise), but the cap post 9510binds against the sensor cap 9120 when the applicator cap 9506 isrotated in a second direction B (e.g., counter clockwise). Moreparticularly, as the applicator cap 9506 (and thus the cap post 9510)rotates in the first direction A, the camming surfaces 9608 engage theramped surfaces 9606, which urge the compliant members 9604 to flex orotherwise deflect radially outward and results in a ratcheting effect.Rotating the applicator cap 9506 (and thus the cap post 9510) in thesecond direction B, however, will drive angled surfaces 9610 of thecamming surfaces 9608 into opposing angled surfaces 9612 of the rampedsurfaces 9606, which results in the sensor cap 9120 binding against thecompliant member(s) 9604.

FIG. 37 is a cross-sectional side view of the sensor control device 9102positioned within the applicator cap 9506, according to one or moreembodiments. As illustrated, the opening to the receiver feature 9602exhibits a first diameter D₃, while the engagement feature 9126 of thesensor cap 9120 exhibits a second diameter D₄ that is larger than thefirst diameter D₃ and greater than the outer diameter of the remainingportions of the sensor cap 9120. As the sensor cap 9120 is extended intothe cap post 9510, the compliant member(s) 9604 of the receiver feature9602 may flex (expand) radially outward to receive the engagementfeature 9126. In some embodiments, as illustrated, the engagementfeature 9126 may provide or otherwise define an angled outer surfacethat helps bias the compliant member(s) 9604 radially outward. Once theengagement feature 9126 bypasses the receiver feature 9602, thecompliant member(s) 9604 are able to flex back to (or towards) theirnatural state and thus lock the sensor cap 9120 within the cap post9510.

As the applicator cap 9506 is threaded to (screwed onto) the housing9504 (FIGS. 35A-35B) in the first direction A, the cap post 9510correspondingly rotates in the same direction and the sensor cap 9120 isprogressively introduced into the cap post 9510. As the cap post 9510rotates, the ramped surfaces 9606 of the compliant members 9604 ratchetagainst the opposing camming surfaces 9608 of the sensor cap 9120. Thiscontinues until the applicator cap 9506 is fully threaded onto (screwedonto) the housing 9504. In some embodiments, the ratcheting action mayoccur over two full revolutions of the applicator cap 9506 before theapplicator cap 9506 reaches its final position.

To remove the applicator cap 9506, the applicator cap 9506 is rotated inthe second direction B, which correspondingly rotates the cap post 9510in the same direction and causes the camming surfaces 9608 (i.e., theangled surfaces 9610 of FIGS. 36A-36B) to bind against the rampedsurfaces 9606 (i.e., the angled surfaces 9612 of FIGS. 36A-36B).Consequently, continued rotation of the applicator cap 9506 in thesecond direction B causes the sensor cap 9120 to correspondingly rotatein the same direction and thereby unthread from the mating member 9118to allow the sensor cap 9120 to detach from the sensor control device9102. Detaching the sensor cap 9120 from the sensor control device 9102exposes the distal portions of the sensor 9112 and the sharp 9114, andthus places the sensor control device 9102 in position for firing (use).

FIG. 38A is a cross-sectional view of a sensor control device 9800showing example interaction between the sensor and the sharp. Afterassembly of the sharp, the sensor should sit in a channel defined by thesharp. The sensor control device in FIG. 9 does not show the sensordeflected inwards and otherwise aligned fully with the sharp, but suchmay be the case upon full assembly as slight bias forces may be assumedby the sensor at the locations indicated by the two arrows A. Biasingthe sensor against the sharp may be advantageous so that any relativemotion between the sensor and the sharp during subcutaneous insertiondoes not expose the sensor tip (i.e., the tail) outside the sharpchannel, which could potentially cause an insertion failure.

FIGS. 38B-38D illustrates an exemplary sharp hub 205014 and sharp 209114configured to not bias the sensor 11900 prior to delivery, for example,during shipping and storage (FIG. 15B) and bias the sensor 11900 duringdelivery of the sensor (FIG. 38C). By storing and shipping the sensor inthe unbiased (relaxed or unstressed) position, the sensor can haveincreased shelf life and lower overall stress. Furthermore, by storingand shipping the sensor in the unbiased position, stress relaxation overshelf life can be reduced and therefore loss in bias force due to stressrelaxation can be limited. Accordingly, bias forces during delivery ofthe sensor can more predictable and biasing during delivery can be asdesigned. The sharp 209114 can include a window 209114A. Prior to use,window 209114A can be aligned with protrusion 11912 on top end 11908 bof the sensor 11900, and protrusion 11912 can extend through window209114. In such a configuration, bottom end 11908 a is not biased towardthe sharp, and accordingly, sensor 11900 can be in a relaxed state.During firing, needle carrier 201102 can be partially retracted, therebypulling sharp 209114 into a partially retracted position. Partialretraction can occur as the sheath 20704 initially moves proximallyrelative the sensor carrier 20710 during firing. Each sharp carrier lockarm 20710K of the sensor carrier 20710 (see FIG. 9D) can extend radiallyoutward as the rib 20710M of the retention arm 20710L engages arespective slot 20704Q of sheath 20704 (see FIG. 8M) which can allowsharp carrier retention feature 20710L to clear the pre-partialretraction retention face 201102A and engage the post-partial retractionretention face 201102B of the sharp carrier 201102 (see FIG. 10C). Inthe partially retracted position, window 209114A no longer receivesprotrusion 11912, and sharp 209114 engages protrusion 11912 to therebybiases the bottom end 11908 a toward the sharp 209114 and into a properposition for delivery, as described above.

Embodiments disclosed herein include:

D. A sensor control device that includes an electronics housingincluding a shell that defines a first aperture and a mount that definesa second aperture alignable with the first aperture when the shell iscoupled to the mount, a seal overmolded onto the mount at the secondaperture and comprising a first seal element overmolded onto a pedestalprotruding from an inner surface of the mount, and a second seal elementinterconnected with the first seal element and overmolded onto a bottomof the mount, a sensor arranged within the electronics housing andhaving a tail extending through the second aperture and past the bottomof the mount, and a sharp that extends through the first and secondapertures and past the bottom of the electronics housing.

E. An assembly that includes a sensor applicator, a sensor controldevice positioned within the sensor applicator and including anelectronics housing including a shell that defines a first aperture anda mount that defines a second aperture alignable with the first aperturewhen the shell is mated to the mount, a seal overmolded onto the mountat the second aperture and comprising a first seal element overmoldedonto a pedestal protruding from an inner surface of the mount, and asecond seal element interconnected with the first seal element andovermolded onto a bottom of the mount, a sensor arranged within theelectronics housing and having a tail extending through the secondaperture and past the bottom of the mount, and a sharp that extendsthrough the first and second apertures and past the bottom of theelectronics housing. The assembly further including a sensor capremovably coupled to the sensor control device at the bottom of themount and defining a sealed inner chamber that receives the tail and thesharp, and an applicator cap coupled to the sensor applicator.

Each of embodiments D and E may have one or more of the followingadditional elements in any combination: Element 1: wherein the mountcomprises a first injection molded part molded in a first shot, and theseal comprises a second injection molded part overmolded onto the firstinjection molded part in a second shot. Element 2: further comprising asharp hub that carries the sharp and sealingly engages the first sealelement, and a sensor cap removably coupled to the sharp hub at thebottom of the mount and sealingly engaging the second seal element,wherein the sensor cap defines an inner chamber that receives the tailand the sharp. Element 3: wherein the sharp hub provides a mating memberthat extends past the bottom of the mount and the sensor cap isremovably coupled to the mating member. Element 4: further comprisingone or more pockets defined on the bottom of the mount at the secondaperture, and one or more projections defined on an end of the sensorcap and receivable within the one or more pockets when the sensor cap iscoupled to the sharp hub. Element 5: further comprising a collarpositioned within the electronics housing and defining a centralaperture that receives and sealingly engages the first seal element in aradial direction. Element 6: further comprising a channel defined on theinner surface of the mount and circumscribing the pedestal, an annularlip defined on an underside of the collar and matable with the channel,and an adhesive provided in the channel to secure and seal the collar tothe mount at the channel. Element 7: further comprising a groove definedthrough the annular lip to accommodate a portion of the sensor extendinglaterally within the mount, wherein the adhesive seals about the sensorat the groove. Element 8: further comprising a collar channel defined onan upper surface of the collar, an annular ridge defined on an innersurface of the shell and matable with the collar channel, and anadhesive provided in the collar channel to secure and seal the shell tothe collar. Element 9: wherein one or both of the first and second sealelements define at least a portion of the second aperture. Element 10:wherein the first seal element extends at least partially through thefirst aperture when the shell is coupled to the mount.

Element 11: wherein the sensor control device further includes a sharphub that carries the sharp and sealingly engages the first seal element,and wherein the sensor cap is removably coupled to the sharp hub at thebottom of the mount and sealingly engages the second seal element.Element 12: wherein the sensor control device further includes one ormore pockets defined on the bottom of the mount at the second aperture,and one or more projections defined on an end of the sensor cap andreceivable within the one or more pockets when the sensor cap is coupledto the sharp hub. Element 13: wherein the sensor control device furtherincludes a collar positioned within the electronics housing and defininga central aperture that receives and sealingly engages the first sealelement in a radial direction. Element 14: wherein the sensor controldevice further includes a channel defined on the inner surface of themount and circumscribing the pedestal, an annular lip defined on anunderside of the collar and matable with the channel, and an adhesiveprovided in the channel to secure and seal the collar to the mount atthe channel. Element 15: wherein the sensor control device furtherincludes a groove defined through the annular lip to accommodate aportion of the sensor extending laterally within the mount, and whereinthe adhesive seals about the sensor at the groove. Element 16: whereinthe sensor control device further includes a collar channel defined onan upper surface of the collar, an annular ridge defined on an innersurface of the shell and matable with the collar channel, and anadhesive provided in the collar channel to secure and seal the shell tothe collar. Element 17: wherein one or both of the first and second sealelements define at least a portion of the second aperture. Element 18:wherein the first seal element extends at least partially through thefirst aperture.

By way of non-limiting example, exemplary combinations applicable to Dand E include: Element 2 with Element 3; Element 2 with Element 4;Element 5 with Element 6; Element 6 with Element 7; Element 5 withElement 8; Element 11 with Element 12; Element 13 with Element 14;Element 14 with Element 15; and Element 13 with Element 16.

Exemplary Firing Mechanism of One-Piece and Two-Piece Applicators

FIGS. 39A-39F illustrate example details of embodiments of the internaldevice mechanics of “firing” the applicator 216 to apply sensor controldevice 222 to a user and including retracting sharp 1030 safely backinto used applicator 216. All together, these drawings represent anexample sequence of driving sharp 1030 (supporting a sensor coupled tosensor control device 222) into the skin of a user, withdrawing thesharp while leaving the sensor behind in operative contact withinterstitial fluid of the user, and adhering the sensor control deviceto the skin of the user with an adhesive. Modification of such activityfor use with the alternative applicator assembly embodiments andcomponents can be appreciated in reference to the same by those withskill in the art. Moreover, applicator 216 may be a sensor applicatorhaving one-piece architecture or a two-piece architecture as disclosedherein.

Turning now to FIG. 39A, a sensor 1102 is supported within sharp 1030,just above the skin 1104 of the user. Rails 1106 (optionally three ofthem) of an upper guide section 1108 may be provided to controlapplicator 216 motion relative to sheath 318. The sheath 318 is held bydetent features 1110 within the applicator 216 such that appropriatedownward force along the longitudinal axis of the applicator 216 willcause the resistance provided by the detent features 1110 to be overcomeso that sharp 1030 and sensor control device 222 can translate along thelongitudinal axis into (and onto) skin 1104 of the user. In addition,catch arms 1112 of sensor carrier 1022 engage the sharp retractionassembly 1024 to maintain the sharp 1030 in a position relative to thesensor control device 222.

In FIG. 39B, user force is applied to overcome or override detentfeatures 1110 and sheath 318 collapses into housing 314 driving thesensor control device 222 (with associated parts) to translate down asindicated by the arrow L along the longitudinal axis. An inner diameterof the upper guide section 1108 of the sheath 318 constrains theposition of carrier arms 1112 through the full stroke of thesensor/sharp insertion process. The retention of the stop surfaces 1114of carrier arms 1112 against the complimentary faces 1116 of the sharpretraction assembly 1024 maintains the position of the members withreturn spring 1118 fully energized.

In FIG. 39C, sensor 1102 and sharp 1030 have reached full insertiondepth. In so doing, the carrier arms 1112 clear the upper guide section1108 inner diameter. Then, the compressed force of the coil returnspring 1118 drives angled stop surfaces 1114 radially outward, releasingforce to drive the sharp carrier 2102 of the sharp retraction assembly1024 to pull the (slotted or otherwise configured) sharp 1030 out of theuser and off of the sensor 1102 as indicated by the arrow R in FIG. 39D.

With the sharp 1030 fully retracted as shown in FIG. 39E, the upperguide section 1108 of the sheath 318 is set with a final locking feature1120. As shown in FIG. 39F, the spent applicator assembly 216 is removedfrom the insertion site, leaving behind the sensor control device 222,and with the sharp 1030 secured safely inside the applicator assembly216. The spent applicator assembly 216 is now ready for disposal.

Operation of the applicator 216 when applying the sensor control device222 is designed to provide the user with a sensation that both theinsertion and retraction of the sharp 1030 is performed automatically bythe internal mechanisms of the applicator 216. In other words, thepresent invention avoids the user experiencing the sensation that he ismanually driving the sharp 1030 into his skin. Thus, once the userapplies sufficient force to overcome the resistance from the detentfeatures of the applicator 216, the resulting actions of the applicator216 are perceived to be an automated response to the applicator being“triggered.” The user does not perceive that he is supplying additionalforce to drive the sharp 1030 to pierce his skin despite that all thedriving force is provided by the user and no additional biasing/drivingmeans are used to insert the sharp 1030. As detailed above in FIG. 39C,the retraction of the sharp 1030 is automated by the coil return spring1118 of the applicator 216.

With respect to any of the applicator embodiments described herein, aswell as any of the components thereof, including but not limited to thesharp, sharp module and sensor module embodiments, those of skill in theart will understand that said embodiments can be dimensioned andconfigured for use with sensors configured to sense an analyte level ina bodily fluid in the epidermis, dermis, or subcutaneous tissue of asubject. In some embodiments, for example, sharps and distal portions ofanalyte sensors disclosed herein can both be dimensioned and configuredto be positioned at a particular end-depth (i.e., the furthest point ofpenetration in a tissue or layer of the subject's body, e.g., in theepidermis, dermis, or subcutaneous tissue). With respect to someapplicator embodiments, those of skill in the art will appreciate thatcertain embodiments of sharps can be dimensioned and configured to bepositioned at a different end-depth in the subject's body relative tothe final end-depth of the analyte sensor. In some embodiments, forexample, a sharp can be positioned at a first end-depth in the subject'sepidermis prior to retraction, while a distal portion of an analytesensor can be positioned at a second end-depth in the subject's dermis.In other embodiments, a sharp can be positioned at a first end-depth inthe subject's dermis prior to retraction, while a distal portion of ananalyte sensor can be positioned at a second end-depth in the subject'ssubcutaneous tissue. In still other embodiments, a sharp can bepositioned at a first end-depth prior to retraction and the analytesensor can be positioned at a second end-depth, wherein the firstend-depth and second end-depths are both in the same layer or tissue ofthe subject's body.

Additionally, with respect to any of the applicator embodimentsdescribed herein, those of skill in the art will understand that ananalyte sensor, as well as one or more structural components coupledthereto, including but not limited to one or more spring-mechanisms, canbe disposed within the applicator in an off-center position relative toone or more axes of the applicator. In some applicator embodiments, forexample, an analyte sensor and a spring mechanism can be disposed in afirst off-center position relative to an axis of the applicator on afirst side of the applicator, and the sensor electronics can be disposedin a second off-center position relative to the axis of the applicatoron a second side of the applicator. In other applicator embodiments, theanalyte sensor, spring mechanism, and sensor electronics can be disposedin an off-center position relative to an axis of the applicator on thesame side. Those of skill in the art will appreciate that otherpermutations and configurations in which any or all of the analytesensor, spring mechanism, sensor electronics, and other components ofthe applicator are disposed in a centered or off-centered positionrelative to one or more axes of the applicator are possible and fullywithin the scope of the present disclosure.

A number of deflectable structures are described herein, including butnot limited to deflectable detent snaps 1402, deflectable locking arms1412, sharp carrier lock arms 1524, sharp retention arms 1618, andmodule snaps 2202. These deflectable structures are composed of aresilient material such as plastic or metal (or others) and operate in amanner well known to those of ordinary skill in the art. The deflectablestructures each has a resting state or position that the resilientmaterial is biased towards. If a force is applied that causes thestructure to deflect or move from this resting state or position, thenthe bias of the resilient material will cause the structure to return tothe resting state or position once the force is removed (or lessened).In many instances these structures are configured as arms with detents,or snaps, but other structures or configurations can be used that retainthe same characteristics of deflectability and ability to return to aresting position, including but not limited to a leg, a clip, a catch,an abutment on a deflectable member, and the like.

Additional details of suitable devices, systems, methods, components andthe operation thereof along with related features are set forth inInternational Publication No. WO2018/136898 to Rao et. al.,International Publication No. WO2019/236850 to Thomas et. al.,International Publication No. WO2019/236859 to Thomas et. al.,International Publication No. WO2019/236876 to Thomas et. al., and U.S.Patent Publication No. 2020/0196919, filed Jun. 6, 2019, each of whichis incorporated by reference in its entirety herein. Further detailsregarding embodiments of applicators, their components, and variantsthereof, are described in U.S. Patent Publication Nos. 2013/0150691,2016/0331283, and 2018/0235520, all of which are incorporated byreference herein in their entireties and for all purposes. Furtherdetails regarding embodiments of sharp modules, sharps, theircomponents, and variants thereof, are described in U.S. PatentPublication No. 2014/0171771, which is incorporated by reference hereinin its entirety and for all purposes.

It should be noted that all features, elements, components, functions,and steps described with respect to any embodiment provided herein areintended to be freely combinable and substitutable with those from anyother embodiment. If a certain feature, element, component, function, orstep is described with respect to only one embodiment, then it should beunderstood that that feature, element, component, function, or step canbe used with every other embodiment described herein unless explicitlystated otherwise. This paragraph therefore serves as antecedent basisand written support for the introduction of claims, at any time, thatcombine features, elements, components, functions, and steps fromdifferent embodiments, or that substitute features, elements,components, functions, and steps from one embodiment with those ofanother, even if the following description does not explicitly state, ina particular instance, that such combinations or substitutions arepossible. Thus, the foregoing description of specific embodiments of thedisclosed subject matter has been presented for purposes of illustrationand description. It is explicitly acknowledged that express recitationof every possible combination and substitution is overly burdensome,especially given that the permissibility of each and every suchcombination and substitution will be readily recognized by those ofordinary skill in the art.

While the embodiments are susceptible to various modifications andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It will be apparent tothose skilled in the art that various modifications and variations canbe made in the method and system of the disclosed subject matter withoutdeparting from the spirit or scope of the disclosed subject matter.Thus, it is intended that the disclosed subject matter includemodifications and variations that are within the scope of the appendedclaims and their equivalents. Furthermore, any features, functions,steps, or elements of the embodiments may be recited in or added to theclaims, as well as negative limitations that define the inventive scopeof the claims by features, functions, steps, or elements that are notwithin that scope.

1. An applicator for delivering a sensor control device, the applicatorcomprising: a housing; a sensor carrier coupled to the housing, thesensor carrier including a first lock interface; a sheath, slidablycoupled to the housing to move between an extended position and acollapsed position, the sheath including a first lock arm having anattached distal end and a free proximal end, the free proximal endincluding a first lock arm interface disposed on an inner surface of thefirst lock arm and a first sharp edge disposed on an outer surface ofthe first lock arm; and a cap threadably coupled to the housing, the capincluding an inner surface having a first plurality of crush ribs;wherein the inner surface of the cap is configured to urge the firstlock arm inwardly when the cap is coupled to the housing such that thefirst lock arm interface engages the first lock interface; and whereinthe first sharp edge is configured to engage the first plurality ofcrush ribs during a shock event.
 2. The applicator of claim 1, whereinthe sensor carrier further comprises a second lock interface; and thesheath further comprises a second lock arm having an attached distal endand a free proximal end, the free proximal end including a second lockarm interface disposed on an inner surface of the second lock arm and asecond sharp edge disposed on an outer surface of the first lock arm;wherein the inner surface of the cap is configured to urge the secondlock arm inwardly when the cap is coupled to the housing such that thesecond lock arm interface engages the second lock interface.
 3. Theapplicator of claim 2, wherein the cap further comprises a secondplurality of crush ribs; and wherein the second sharp edge is configuredto engage the second plurality of crush ribs during the shock event. 4.The applicator of claim 1, wherein the first lock arm interfacecomprises a U-shape.
 5. The applicator of claim 1, wherein the firstlock interface is disposed on a perimeter of the sensor carrier.
 6. Theapplicator of claim 1, further comprising a housing skirt coupled to thehousing by a plurality of skirt stiffening ribs.
 7. The applicator ofclaim 6, further comprising a tamper evidence feature coupled to each ofthe housing skirt and the cap.
 8. The applicator of claim 7, wherein thetamper evidence feature comprises a sticker.
 9. The applicator of claim1, wherein the housing comprises cyclic olefin copolymer.
 10. Theapplicator of claim 1, wherein the sheath comprises Delrin.
 11. Theapplicator of claim 1, wherein the cap comprises high densitypolyethylene.
 12. The applicator of claim 1, wherein the sensor carrierfurther comprises a base having a first half and a second half; a firstsensor retention arm coupled to the first half of the base at a firstend portion of the first sensor retention arm and having a free secondend portion extending toward the second half of the base, the firstsensor retention arm including a first sensor retention feature on aninner surface of the first sensor retention arm and wherein the firstlock interface is disposed on an outer surface of the first sensorretention arm.
 13. The applicator of claim 12, wherein the sensorcarrier further comprises three equally spaced housing attachmentfeatures extending upwardly from a top surface of the base, each housingattachment feature including: a housing snap; a housing locatingfeature; and a housing biasing feature.
 14. The applicator of claim 13,wherein the housing comprises three sensor carrier attachment features,each configured to engage one of the sensor carrier housing attachmentfeatures.
 15. The applicator of claim 1, wherein the cap furthercomprises a sheath support surface configured to engage the sheath andlimit movement of the sheath during the shock event.
 16. The applicatorof claim 1, wherein the cap further comprises a raised ridge configuredto limit movement of the sensor carrier during a shock event. 17-36.(canceled)